Monthly Archives: November 2021

1.Researchers Clarify the Identity of Stem Cells byUniversity of Calgary.Source:https://medicalxpress.com/news/2018-05-identity-brain-stem-cells.html

2.Bone Marrow Diseases byU.S. National Library of Medicine.Source:https://medlineplus.gov/bonemarrowdiseases.html

3.NCI Dictionary of Cancer Terms byNational Cancer Institute.Source:https://www.cancer.gov/publications/dictionaries/cancer-terms/def/blood-stem-cell

4.Muscle Stem Cells byNature.Source:https://www.nature.com/subjects/muscle-stem-cells

5.Stem Cells: Where Do They Live and What They Can Do? byEuroStemCell.Source:https://www.eurostemcell.org/skin-stem-cells-where-do-they-live-and-what-can-they-do

6.Liver Stem Cells byMatthews VB, Yeoh GC.Source:https://www.ncbi.nlm.nih.gov/pubmed/16118112

7.Regeneration in Humans byWikipedia.Source:https://en.wikipedia.org/wiki/Regeneration_in_humans#Naturally_regenerating_appendages_and_organs

8.Stem Cells in the Umbilical Cord byMark L. Weiss, Deryl L. Troyer.Source:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3753204/

9.Stem Cell Information byNational Institutes of Health.Source:https://stemcells.nih.gov/glossary.htm#ivf

10.Stem Cell Laws byWikipedia.Source:https://en.wikipedia.org/wiki/Stem_cell_laws#United_States

11.First Person Treated in Milestone Stem Cell Trial byAndy Coghlan.Source:https://www.newscientist.com/article/dn19570-first-person-treated-in-milestone-stem-cell-trial

12.Regulatory Considerations for Human Cells, Tissues, and Cellular and TissueBased Products: Minimal Manipulation and Homologous Use byFood and Drug Administration.Source:link

13.After Surgery: Discomforts and Complications byUniversity of Rochester.Source:https://www.urmc.rochester.edu/encyclopedia/content.aspx?ContentTypeID=85&ContentID=P01390

14.What proportion of patients report long-term pain after total hip or knee replacement for osteoarthritis? A systematic review of prospective studies in unselected patients byBeswick AD, Wylde V, Gooberman-Hill R, et al. Source:https://bmjopen.bmj.com/content/2/1/e000435

15.Many diseases increase the risks of hip fracture surgery byUniversity of Eastern Finland.Source:https://www.sciencedaily.com/releases/2018/11/181130111645.htm

16.Complications of total hip arthroplasty byGreg A Erens, MD. Source:https://www.uptodate.com/contents/complications-of-total-hip-arthroplasty

17.Reis RC, de Oliveira MF, Rotta JM, Botelho RV. Risk of complications in spine surgery: a prospective study. Open Orthop J. 2015;9:20-5. Published 2015 Jan 31. doi:10.2174/1874325001509010020. Source:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4321205/

18.Proietti L, Scaramuzzo L, Schiro GR, Sessa S, Logroscino CA. Complications in lumbar spine surgery: A retrospective analysis. Indian J Orthop. 2013;47(4):340-5. Source:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3745686/

19.Kroslak, M., & Murrell, G. A. C. (2018). Surgical Treatment of Lateral Epicondylitis: A Prospective, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial. The American Journal of Sports Medicine, 46(5), 11061113. Source:https://journals.sagepub.com/doi/abs/10.1177/0363546517753385

20.Hackl M, Beyer F, Wegmann K, Leschinger T, Burkhart KJ, Mller LP. The treatment of simple elbow dislocation in adults. Dtsch Arztebl Int. 2015;112(18):311-9. Source:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4455254/

21.Backhouse MR, Vinall-Collier KA, Redmond AC, Helliwell PS, Keenan AM. Interpreting outcome following foot surgery in people with rheumatoid arthritis. J Foot Ankle Res. 2016;9:20. Published 2016 Jul 8. doi:10.1186/s13047-016-0153-6. Source:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4938997/

22.Chou LB, Wagner D, Witten DM, et al. Postoperative pain following foot and ankle surgery: a prospective study. Foot Ankle Int. 2008;29(11):1063-8. Source:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2743476/

23.Kise Nina Jullum, Risberg May Arna, Stensrud Silje, Ranstam Jonas, Engebretsen Lars, Roos Ewa M et al. Exercise therapy versus arthroscopic partial meniscectomy for degenerative meniscal tear in middle aged patients: randomised controlled trial with two year follow-up BMJ 2016; 354 :i3740. Source:https://www.bmj.com/content/354/bmj.i3740

24.Beaufils P, Becker R, Kopf S, Matthieu O, Pujol N. The knee meniscus: management of traumatic tears and degenerative lesions. EFORT Open Rev. 2017;2(5):195-203. Published 2017 May 11. doi:10.1302/2058-5241.2.160056. Source:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5489759/

25.New hip and knee replacements more likely to need repeat surgery byKate Devlin.Source:https://www.telegraph.co.uk/news/uknews/2663548/New-hip-and-knee-replacements-more-likely-to-need-repeat-surgery.html

26.Repeat hip and knee replacements cost $130 million annually byCanadian Institute for Health Information.Source:https://www.cihi.ca/en/repeat-hip-and-knee-replacements-cost-130-million-annually

27.Kain MS, Marcantonio AJ, Iorio R. Revision surgery occurs frequently after percutaneous fixation of stable femoral neck fractures in elderly patients. Clin Orthop Relat Res. 2014;472(12):4010-4. Source:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4397802/

28.Many young ACL surgery patients need second surgery later on byHospital for Special Surgery.Source:https://www.sciencedaily.com/releases/2015/05/150501103455.htm

29.Osteoarthritis and stem cell therapy in humans: a systematic review byJevotovsky DS, Alfonso AR, Einhorn TA, Chiu ES.Source:https://www.ncbi.nlm.nih.gov/pubmed/29544858

30.Cell-Based Therapies for Lumbar Discogenic Low Back Pain: Systematic Review and Single-Arm Meta-analysis. Wu T, Song HX, Dong Y, Li JH. Spine (Phila Pa 1976). 2018 Jan 1;43(1):49-57. doi: 10.1097/BRS.0000000000001549. Source:https://www.ncbi.nlm.nih.gov/pubmed/26953666

31.Fan X, Wang JZ, Lin XM, Zhang L. Stem cell transplantation for spinal cord injury: a meta-analysis of treatment effectiveness and safety. Neural Regen Res. 2017;12(5):815-825. Source:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5461621/

32.Lopes L, Setia O, Aurshina A, Liu S, Hu H, Isaji T, Liu H, Wang T, Ono S, Guo

X, Yatsula B, Guo J, Gu Y, Navarro T, Dardik A. Stem cell therapy for diabetic

foot ulcers: a review of preclinical and clinical research. Stem Cell Res Ther.

2018 Jul 11;9(1):188. doi: 10.1186/s13287-018-0938-6. PubMed PMID: 29996912;

PubMed Central PMCID: PMC6042254. Source:https://www.ncbi.nlm.nih.gov/pubmed/29996912

33.Hernigou P, Flouzat Lachaniette CH, Delambre J, Zilber S, Duffiet P,

Chevallier N, Rouard H. Biologic augmentation of rotator cuff repair with

mesenchymal stem cells during arthroscopy improves healing and prevents further

tears: a case-controlled study. Int Orthop. 2014 Sep;38(9):1811-8. doi:

10.1007/s00264-014-2391-1. Epub 2014 Jun 7. PubMed PMID: 24913770. Source:https://www.ncbi.nlm.nih.gov/pubmed/24913770

34.Rafael Nadal to undergo stem-cell treatments on his injured back byMatt Bonesteel.Source:https://www.washingtonpost.com/news/early-lead/wp/2014/11/10/rafael-nadal-to-undergo-stem-cell-treatments-on-his-injured-back/?utm_term=.c3e7dbd2f4c7

35.Pau Gasol has knee procedure, to receive stem cell injections byEric Pincus.Source:https://www.latimes.com/sports/lakers/lakersnow/la-sp-ln-lakers-pau-gasol-knee-procedure-20130509-story.html

36.Peyton Manning Underwent Stem Cell Treatment For Neck Injury byAmanda L. Chan.Source:https://www.huffpost.com/entry/peyton-manning-stem-cell-treatment_n_970763

37.Cristiano Ronaldo will undergo stem cell treatment as Real Madrid star races to be fit to face Manchester City in second-leg clash byOliver Todd.Source:https://www.dailymail.co.uk/sport/football/article-3562460/Cristiano-Ronaldo-undergo-stem-cell-treatment-Real-Madrid-star-races-fit-face-Manchester-City-second-leg-clash.html

38.What Is This Knee Treatment Kobe Bryant Goes All the Way to Germany For? byWill Carroll.Source:https://bleacherreport.com/articles/1798763-what-is-this-knee-treatment-kobe-bryant-goes-all-the-way-to-germany-for

39.PRP Therapy Helps Tiger Woods Recover byCedar Stem Cell Institute.Source:https://www.cedarsci.com/blog/prp-therapy-tiger-woods/

40.PRP, stem cell and Warriors G Steph Currys quick return from knee injury byJohn Canzano.Source:https://www.oregonlive.com/sports/oregonian/john_canzano/2016/04/steph_currys_return_from_mcl_s.html

41.STEM CELL THERAPY PLAYS A CRUCIAL ROLE FOR ATHLETES IN THE 2012 OLYMPIC GAMES: KOBE BRYANT, DARA TORRES AND DAVID PAYNE byMetro MD.Source:https://www.metro-md.com/stem-cell-therapy-plays-a-crucial-role-for-athletes-in-the-2012-olympic-games-kobe-bryant-dara-torres-and-david-payne/

42.Greens stem-cell success story bodes well for Manning byAlbert Breer.Source:http://www.nfl.com/news/story/09000d5d8227e0ce/article/greens-stemcell-success-story-bodes-well-for-manning

43.Mikirova NA, Casciari JJ, Hunninghake RE, Beezley MM. Effect of weight

reduction on cardiovascular risk factors and CD34-positive cells in circulation.

Int J Med Sci. 2011;8(6):445-52. Epub 2011 Aug 1. PubMed PMID: 21850193; PubMed

Central PMCID: PMC3156990. Source:https://www.ncbi.nlm.nih.gov/pubmed/21850193

44.Cerletti M, Jang YC, Finley LW, Haigis MC, Wagers AJ. Short-term calorie restriction enhances skeletal muscle stem cell function. Cell Stem Cell. 2012;10(5):515-9. Source:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3561899/

45.Mazzoccoli G, Tevy MF, Borghesan M, Delle Vergini MR, Vinciguerra M. Caloric

restriction and aging stem cells: the stick and the carrot? Exp Gerontol. 2014

Feb;50:137-48. doi: 10.1016/j.exger.2013.10.014. Epub 2013 Nov 6. Review. PubMed

PMID: 24211426. Source:https://www.ncbi.nlm.nih.gov/pubmed/24211426

46.The Okinawa diet could it help you live to 100? byMichael Booth.Source:https://www.theguardian.com/lifeandstyle/2013/jun/19/japanese-diet-live-to-100

47.Saki N, Jalalifar MA, Soleimani M, Hajizamani S, Rahim F. Adverse effect of high glucose concentration on stem cell therapy. Int J Hematol Oncol Stem Cell Res. 2013;7(3):34-40. Source:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3913149/

48.Ceccarelli G, Benedetti L, Arcari ML, Carubbi C, Galli D. Muscle Stem Cell and Physical Activity: What Point is the Debate at?. Open Med (Wars). 2017;12:144-156. Published 2017 Jul 24. doi:10.1515/med-2017-0022. Source:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5529938/

49.Mbius-Winkler S, Hilberg T, Menzel K, Golla E, Burman A, Schuler G, Adams V.

Time-dependent mobilization of circulating progenitor cells during strenuous

exercise in healthy individuals. J Appl Physiol (1985). 2009 Dec;107(6):1943-50.

doi: 10.1152/japplphysiol.00532.2009. Epub 2009 Oct 1. PubMed PMID: 19797690. Source:https://www.ncbi.nlm.nih.gov/pubmed/19797690

50.Schmidt A, Bierwirth S, Weber S, Platen P, Schinkthe T, Bloch W. Short

intensive exercise increases the migratory activity of mesenchymal stem cells. Br

J Sports Med. 2009 Mar;43(3):195-8. Epub 2007 Dec 10. PubMed PMID: 18070806. Source:https://www.ncbi.nlm.nih.gov/pubmed/18070806

51.Stories of Hope: A Stem Cell Therapy for Diabetes byCalifornias Stem Cell Agency.Source:https://www.cirm.ca.gov/our-progress/stories-hope-stem-cell-therapy-diabetes

52. Miana VV, Gonzlez EAP. Adipose tissue stem cells in regenerative medicine. Ecancermedicalscience. 2018;12:822. Published 2018 Mar 28. doi:10.3332/ecancer.2018.822. Source:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5880231/

53. FDA announces comprehensive regenerative medicine policy framework byFood and Drug Administration.Source:https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm585345.htm

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Stem Cell Therapy, Explained: Everything You Need To Know

"Stem cells have enormous potential for alleviating suffering for many diseases which currently have no effective therapy. The field has progressed to the clinic and it is important that this pathway is underpinned by excellent science and rigorous standards of clinical research. The journal provides an important avenue of publication in translational aspects of stem cell therapy spanning preclinical studies, clinical research and commercialization."

Timothy O'Brien,Editor-in-Chief,Stem Cell Research & Therapy

"The study of stem cells is one of the most exciting areas of contemporary biomedical research. We believe that Stem Cell Research & Therapy will act as a highly active forum for both basic and translational research into stem cell biology and therapies. Specifically, by developing this forum for cutting edge research, we hope that Stem Cell Research & Therapy will play a significant role in bringing together the critical information to synergize stem cell science with stem cell therapies."

Rocky S Tuan,Editor-in-Chief,Stem Cell Research & Therapy

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Stem Cell Research & Therapy | Home page

Stem Cell Therapy for a Herniated Disc

A herniated disc is one of the major concerns of Modern Healthcare. Stem cell treatment for a herniated disc has opened new ways of non-surgical treatment of this syndrome by just an injection. The procedure involved injecting stem cells in the ruptured disc to stimulate the repair and provide relief from the extreme pain. The procedure has been fruitful in providing relief to people of all ages suffering from a herniated disc.

The stem cells injected into the patient body repairs herniated a disc and bring it back in shape. The body gets naturally repaired by this procedure and improves faster than any other surgical process.

There can be multiple reasons for a herniated disc. Regular wear and tear caused to the bone due to aging, heavy lifting and any traumatic events may be the cause of such issues.

The other reasons can be:

Overweight Too much of body weight can create extra pressure on the spine and lead to a herniated disc in the lower spinal region.

Extreme physical strain in work People engaged in particular occupations that include extreme physical stress or heavy lifting can cause discomfort in the back and cause a herniated disc. Pulling and pushing of heavy object in work also affect the back badly to rupture the disc.

Improper body posture Another important reason for a herniated disc is improper posters while standing or sitting.

Genetic Some people are genetically predisposed to be affected by a herniated disc.

Generally, a herniated disc occurs in the lumbar spine or the lower back. However, in some cases, it may occur in the cervical spine near the neck. The major symptoms of a herniated disc are as follows:

Limb pains Herniated disc cause in the limbs, thighs, buttocks, neck, shoulder, arms and calves. The pain pumps up while sneezing or coughing.

Numbness in certain body parts Herniated disc causes a tingling sensation, or sometimes numbness in various body parts as the nerves remain blocked. The same body parts also suffer from extreme pain in case treatment is delayed.

Weakness in muscles As the nerves get choked, the body muscles tend to lose strength. The body finds it difficult to perform strenuous works.

In rare cases, the body does not show any symptoms and are only diagnosed after imaging tests.

There are two steps of herniated disc treatment. Firstly the stem cells are collected from the patients bone marrow and in the second step are injected into the affected region. This cures and heals the ruptured disc as it gets more oxygen and improved immunity.

Bone marrow aspiration is done to collect stem cells. The hip is numbed to execute this procedure of inserting the needle to it and extract samples of bone marrow. Numbness in the hip makes it painless for the patients to go through the entire procedure.

The series is followed by a number of injections in the next 7 days to push back the stem cells to the body. The patient is sent for recovery after the stem cells are pushed back to her body. This can be a painful phase for patients for the first 3 to 4 weeks, but eventually, the pain gets off. Most patients have not a complaint of any pain after the procedure for more than 2 years.

The foremost benefit related to Stem Cell Therapy for a Herniated Disc is that the body gets to repair itself by its own. No external agent is pushed in the body for it to heal. The only thing it requires is the right execution of the procedure by qualified medical coordinators.

Also, this noninvasive procedure is popular due to its positive results in extreme cases of herniated discs. No artificial device is placed in the spine in this procedure and the disc ruptures are naturally cured.

The treatment for Stem Cell Therapy for a Herniated Disc is around $10, 000 on an average. The price depends on the experience of the medical practitioners executing the procedure, location and hospital facilities related to the recovery.

Stem Cell Therapy for a Herniated Disc costs much lower in Latin American countries like Mexico as medical expenses in this part of the world is way more affordable than any other places.

Like any other medical procedure, the success of Stem Cell Therapy for a Herniated Disc depends on the qualification and experience of the doctor performing it. It is very important to research the infrastructure and facilities of the hospital offering Stem Cell Therapy for a Herniated Disc before you register for it. Apart from this, it is equally important to know about the doctor who is performing this treatment for you. Once you have well research about these two things, you are one step ahead for a successful Stem Cell Therapy for a Herniated Disc treatment procedure.

If you are already suffering from a herniated disc and want to learn more about how stem cell therapy can work for you then use the button below:

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Stem Cell Therapy for a Herniated Disc - Global Stemcell ...

The stem cell procedure for the treatment of knee pain is minimally invasive, takes about 3 hours, and patients walk out of the office on their own following treatment. To start, stem cells are harvested from your abdominal or love handle fat using high tech, minimally-invasive liposuction equipment. Stem cells from your bone marrow are also utilized. The bone marrow concentrate is harvested using a specially designed, low-trauma needle which is placed into the posterior iliac crest under live x-ray guidance.

Mild IV sedation, in combination with local anesthetic, is used to provide patient comfort during the procedure. The harvested cells are then prepared for injection using an advanced separation and centrifugation process.

With the use of live x-ray guidance, the cells and growth factors are injected into the affected knee joint under sterile conditions. Dr. Brandts extensive experience with knee injections, along with the aid of the appropriate image guidance, ensures the cells are reaching their targeted area so you have the best chance for improvement.

To complement the high stem cell count achieved with the use of adipose derived stem cells, we often utilize PRP, A2M, and placental derived growth factors during our knee procedures and follow-up treatments.

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Stem Cell Therapy for Knees: Definitive Guide [with ...

Q: What are the types of stem cell therapy?

A: Stem cells are primitive cells that are capable of self-renewal (i.e., to divide to replenish their population); are pluripotent (i.e., able to differentiate into different mature cells); and are able to create, maintain, or repair tissues. There are several general categories of stem cells, including:

Two general stem-cell-based therapeutic strategies have been considered in MS:1

This document addresses AHSCT and MSC transplantation separately.

A: AHSCT is a multi-step procedure, which includes:

Mobilization typically is performed as an outpatient. Conditioning, PBHSC infusion, and initial recovery usually are performed during an approximately 1-month hospitalization in a specialized transplant unit.

A: A sizable number of case series, uncontrolled phase 2 clinical trials, and randomized clinical trials have demonstrated, in aggregate, potent efficacy of AHSCT in patients with active relapsing MS, including marked reduction in relapses, MRI lesion activity, and brain volume loss (after initial acceleration).1-3 In two analyses, the rate of no evidence of disease activity at 2 years was 70-90% in AHSCT case series and trials compared to 15-50% in clinical trials of MS disease modifying therapies (DMTs).4,5 A sizable proportion of patients treated with AHSCT demonstrate improvement in disability, for example, 64% at 4 years in a recent case series.6 Disease control often is durable, lasting up to 15 years or more without the need for ongoing disease modifying therapy (DMT) in many patients.7 Nonetheless, some patients require resumption of standard DMTs at some point after AHSCT, particularly with lower intensity non-myeloablative conditioning regimens.

The potent efficacy is attributed to immunoablative conditioning that depletes pathogenic immune cells; the durability of benefit is attributed more normal regulatory function and T-cell and B-cell repertoires following immune reconstitution.4

A: Early toxicity is common in patients undergoing AHSCT and potentially includes MS relapse during mobilization and conditioning, complications of leukapheresis, side effects of cytotoxic agents comprising the conditioning regimen (e.g., nausea or infertility), complications of myelosupression (e.g., infection or bleeding complications), and engraftment syndrome after re-infusion of PBHSCs (fever, rash, pulmonary edema, liver or renal impairment, and encephalopathy). Patients typically are hospitalized for approximately 1 month when undergoing conditioning and transplantation, and for initial recovery. Previous estimates of overall transplant-related mortality in MS were 2% or more. The current estimate is 0.2-0.3% for AHSCT performed after 2012.4 The improved safety is due to increased experience with the procedure, refinement of the protocol, and better selection of patients with lower risk of complications.

After recovery, adverse effects are rare and include infection (principally related to herpes zoster) and secondary autoimmune disorders. One potential advantage is that after AHSCT patients typically do not need ongoing MS DMT, with the associated cumulative risk of adverse effects.

A: The estimated cost for uncomplicated AHSCT is approximately $150,000. One potential advantage is that after recovery patients typically do not need ongoing MS DMT, with the associated cumulative cost. Nevertheless, most health insurance plans do not cover AHSCT, so obtaining coverage often is difficult.

A: Patients most likely to benefit from AHSCT are young (approximately 55 years or less), with relatively recent disease onset (approximately 10 years or less), still ambulatory, with highly active MS with recent clinical relapses or MRI lesion activity, and continued disease activity despite treatment with approved DMTs especially high-efficacy DMTs. Both the American Society for Blood and Marrow Transplantation 2 and National MS Society3 have published policy statements that AHSCT is a reasonable option in such patients, who are at high risk for disability.

A: Because of the complexity of the AHSCT procedure and the need for appropriate patient selection and follow-up, AHSCT for MS should be performed by centers with expertise and experience in transplant and that are affiliated with centers with experience and expertise in management of MS.1-3We advise patient not to undergo AHSCT in free-standing transplant clinics, especially in the absence of a detailed plan for follow-up and management of medical and neurologic issues post-transplant.

A: Because of the uncertain efficacy and safety of AHSCT compared to approved DMTs for MS, the Mellen Center is participating in the ongoing Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Multiple Sclerosis (BEAT-MS) clinical trial sponsored by the National Institute of Allergy and Infectious Diseases and the Immune Tolerance Network (ClinicalTrials.gov Identifier: NCT04047628). This multicenter, randomized, rater-blinded trial compares the efficacy, safety, cost-effectiveness, and immunologic effects of AHSCT versus high-efficacy DMTs in participants with highly active, treatment-refractory, relapsing MS.

Because of unanswered questions regarding the efficacy of AHSCT in MS and substantial associated risk, our priority is to enroll patients for whom AHSCT is being considered into the BEAT-MS trial. We will consider AHSCT outside of the BEAT-MS trial for selected patients for whom AHSCT appears indicated but who are not eligible to participate in the study.

A: Typically, transplant physicians monitor and manage transplant-related adverse effects for the first 6 months following uncomplicated AHSCT (longer if there are complications). After 6 months following uncomplicated AHSCT, transplant-related adverse effects are rare. Patients need to be monitored primarily for symptoms or other findings suggesting infection or secondary autoimmune disorders. Long-term MS disease monitoring is similar to typical MS, with clinical visits and periodic MRIs.

A: Several analyses demonstrated that AHSCT has modest or no efficacy in preventing or reversing progressive disability worsening in the absence of recent relapses or MRI lesion activity. Conversely, the risk of adverse effects and transplant-related mortality are increased in progressive MS due to greater neurologic disability, older age, and increased likelihood of comorbidities. Many of the transplant-related deaths in recent series were patients with progressive MS.4 As a result, AHSCT generally is not advised for patients with non-active progressive MS and/or severe disability.

A: A recent publication reported potent efficacy of non-myeloablative AHSCT in preventing relapses, improving disability, and improving quality of life in 11 patients with aquaporin-4-positive neuromyelitis optica spectrum disorders (NMOSD).8 There now are 3 medications with regulatory approval to treat NMOSD plus several other medications used off-label. The findings from this small uncontrolled case series suggests AHSCT might be an option for patients with NMOSD who do not achieve adequate disease control from the available medication options. Rigorous formal clinical trials are needed to more definitively assess the efficacy and safety of AHSCT in NMOSD. We have not performed AHSCT for NMOSD at Cleveland Clinic.

A: Studies of various stem cell approaches to directly replace myelin-forming cells have been proposed (e.g., transplantation of oligodendrocyte progenitor cells or induced pluripotent stem cells), but none has been completed.1 To date, the most experience is with transplantation of mesenchymal stem cells (MSCs), pluripotent stromal cells present in a perivascular niche in a variety of tissues. In addition to their ability to differentiate into mesodermal lineage derivatives (e.g., bone, cartilage, connective tissue, and adipose tissue), MSCs appear to function to limit inflammatory tissue damage and promote tissue repair, including in the central nervous system, through elaboration of a large number of soluble immunomodulatory and trophic factors. These properties have led to a large number of studies investigating the potential benefit of MSC transplantation to treat a wide variety of inflammatory and tissue injury conditions.1 There also are a large number of commercial stem cell clinics offering MSC transplantation for a wide range of conditions.

A: A sizable number of preliminary trials of MSC transplantation in MS have been reported,1 including one conducted at the Mellen Center.9 These studies had different study populations, cell products, routes of administration, and study protocols, making it difficult to generalize the results. In aggregate, the studies reported good safety and tolerability, and some provided preliminary evidence of benefit. A recent study utilizing cell production procedures intended to augment production of neurotrophic factors by the MSCs and multiple intrathecal administrations, reported more prominent efficacy.10

Despite the sizable number of studies of MSC transplantation, there are a many unanswered technical questions, including the best tissue source (e.g., bone marrow, adipose tissue, or placenta/umbilical cord), whether the cells should be autologous (i.e., from the patient) or allogeneic (i.e., from someone without MS), the optimal cell culture methods to maximize yield and stimulate characteristics that increase therapeutic potency, whether the cells can be cryopreserved (frozen and stored) or need to be harvested directly from culture, dose (i.e., how many MSCs are administered), dosing schedule (i.e., for how long the therapeutic benefit lasts and how often the MSCs need to be administered), and optimal route of administration (i.e., intravenous, intrathecal, or both), among other issues. Because of these unanswered technical questions, MSC transplantation currently is an experimental treatment and should not be performed outside of rigorous formal clinical trials

A: There are a large number of commercial stem cell clinics in the U.S. and other countries offering treatments marketed as stem cells and presumed to be predominantly MSCs, on a fee-for service basis. However, because of the lack of quality control, lack of regulatory oversight, and lack of any validation of their efficacy or safety, we strongly advise patients not to pursue stem cell treatments at commercial stem cell clinics, outside of rigorous formal clinical trials. Many of these operations are potentially fraudulent.

Although MSC transplantation generally has been well-tolerated and safe in formal clinical trials, complications have been reported when administered in commercial stem cell clinics, including among other reports severe loss of vision following intravitreal injection11 and malignant spinal cord neoplasm following intrathecal injection.12

In addition, a number of concerns regarding commercial stem cell clinics have been raised: 13,14

A: Patient who undergo MSC transplantation should be monitored for symptoms or other findings indicating potential complications, including local or systemic infection, ectopic tissue formation, neoplasia, and arachnoiditis (following intrathecal administration). Long-term MS disease monitoring is similar to typical MS, with clinical visits and periodic MRIs.

Last Updated: 10 DEC 2020

Approach last updated: February 14, 2021

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Stem Cell Therapy | Mellon Center Approach | Cleveland Clinic

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Excerpt from:
Stem cells: past, present, and future | Stem Cell Research ...

Stem cell therapy can help heart failure (HF) patients decrease their risk of a non-fatal myocardial infarction (MI) or stroke, according to new research presented at the American Heart Associations Scientific Sessions 2021.

Researchers tracked data from 537 patients with heart failure withreduced ejection fraction (HFrEF).Eighty percent of the patients were men, and the median age was 63 years old.

Patients were split into two groups: 261 patients were injected with 150 million mesenchymal precursor cells [stem cells] provided by healthy donors directly into the heart using a catheter, and 276 patients underwent a fake procedure.

According to the authors, patients were discharged from the hospital the day after the procedure and were followed for an average of 30 months.

Overall, the team associated stem cell use with a 65% decrease in non-fatal MIs and stroke events. Also,patients with high levels of inflammation (CRP levels of at least 2 mg/L) were 79% less likely to have non-fatal MI or stroke after being given stem cells.

Moreover, stem cell treatment lowered cardiac death by 80% in patients with high levels of inflammation and less severe HF.

However, the team added, there was no reduction in hospitalizations for HF among patients who received stem cells.

Cell therapy has the potential to change how we treat HF, lead author Emerson C. Perin, MD, PhD, director of the Center for Clinical Research and medical director of the Texas Heart Institute in Houston, said in a prepared statement. This study addresses the inflammatory aspects of HF, which go mostly untreated, despite significant pharmaceutical and device therapy development. Our findings indicate stem cell therapy may be considered for use in addition to standard guideline therapies.

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Stem cell therapy for heart failure lowers risk of adverse outcomes - Cardiovascular Business

Daniel Wiznia, MD, an orthopaedic surgeon with Yale School of Medicine, is practicing a surgical technique designed to render 10% of hip replacements unnecessary. Regenerative properties from a patients own stem cells are responsible for regrowing bone, restoring blood flow, and being able to avoid further interventional surgery.

Osteonecrosis, also known as avascular necrosis, occurs in more than 20,000 Americans each year. As the condition progresses, bone cells known as osteoblasts become unable to repair themselves and sustain the integrity of the bone, and ultimately die. The bone deterioration leads to a decrease in blood flow to the area, further weakening the entire skeletal structure of the upper leg. If unaddressed, the ball portion of the hips ball and socket joint will cave in on itself and collapse, requiring a total hip replacement.

The fact that patients often receive this diagnosis during their 30s and 40s presents a particular challenge. While the lifespan of hip prosthetics has dramatically increased in recent years, a patient who undergoes a total hip arthroplasty, or total hip replacement, at that age will almost certainly require a revision later in life. This redo of the same surgery at an older age comes with an entirely new set of risks and potential complications, making it that much harder to manage down the road.

The goal in patients with this condition then becomes very clear: prevent the head of the femur (thighbone) from collapsing.

Wiznia, assistant professor of orthopaedics and rehabilitation, and of mechanical engineering and materials science, draws from both of those areas of expertise to use 3D imaging technology as part of an innovative joint-preservation procedure. In recent years, he has worked closely with the Yale School of Engineering & Applied Sciences and the Integrated 3D Surgical Team at the Yale School of Medicine to tailor this treatment to each patient. Imaging has proven to be critical to the successful outcome of this surgical technique.

One of the challenges of orthopaedic surgery in the human body is that surgeons are operating in a three-dimensional space and are often reliant on two-dimensional imagery such as X-rays, Wiznia says. Through computer modeling, we are able to customize those images and create models that are specific to each patient, which, in turn, enhances outcomes and overall post-operative success rates.

Wiznia surgically harvests bone marrow from the patients pelvis. By using a centrifuge inside the operating room, he is able to isolate and concentrate the individuals own stem cells. Material containing the stem cells is then injected into the area of bone that has died.

Research has shown that stem cells possess the characteristics and qualities needed for the body to regrow, repair, and regenerate damaged tissue and bone, and according to Wiznia, this treatment dramatically reduces the risk of the head of the femur from collapsing. Soon after the procedure, many patients with avascular necrosis experience rejuvenated blood supply to the area and the bone is repopulated with new cells. This can additionally alleviate the short-term need for a hip replacement.

The major challenge in this patient population is identifying, diagnosing, and performing surgical intervention in time before the collapse. Because the vascular injury is usually a painless event, says Wiznia, patients are generally unaware of the specific point in time when the injury occurred, which is why cases are rarely discovered in time.

Patients may be encouraged to know that those who have avascular necrosis of the hip generally have it present on both sides, and it can develop on the two sides at different rates. So, even if it is detected too late on one side, there is still a chance to preserve the other.

We usually are able to catch that second asymptomatic side in those situations and conduct the core decompression with stem cell treatment before it collapses, Wiznia says. This novel stem cell therapy has demonstrated improved pain and function, and the stem cells decrease the risk of the femoral head from collapsing. That ultimately translates into fewer young patients requiring hip replacements along with subsequent surgeries in their later years.

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Stem Cell Therapy Reduces Need for Nearly 10% of Hip Replacements - Yale School of Medicine

SEATTLE, Nov. 18, 2021 /PRNewswire/ -- According to Latest Report, The global cell and gene therapy marketis estimated to account for 47,095.2 Mn in terms of value by the end of 2028.

Genetic mutations can lead to a wide range of serious malfunctions at the cellular level, including diseases such as cancer. These treatments use "living drugs" to repair damaged tissues and replace diseased organs, and they have the potential to cure a wide variety of ailments. In addition to regenerating damaged organs, cell and gene therapy can cure cancer, and the treatment process is fast-paced, with significant progress made in recent years. For the cell and gene therapy industry to reach its full potential, early interaction with payers and regulators is crucial. This will facilitate a fast-tracked clinical trial. While embracing new platform technologies is challenging, early collaboration with other industries will ensure a faster path to market for the new therapies. In addition to this, a play-to-win attitude is critical to success in this field. The success of gene and cell therapies will depend on achieving clinical and research goals.

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Market Drivers

1. Increasing incidence of cancer and other target diseases is expected to drive growth of the global cell and gene therapy market during the forecast period

With growing incidence of cancer and target diseases such as measles and tuberculosis, the adoption of gene and cell therapy has increased. According to the World Health Organization (WHO), in 2019, around 1.4 million people died from tuberculosis worldwide with around 10 million people being diagnosed with the same. According to the same source, in 2018, around 9.6 million died due to cancer with over 300,000 new cases of cancer being diagnosed each year among children aged 0-19 years across the globe. Gene therapy uses genes to treat or prevent disease, where it allows doctors to insert a gene into a patient's cells instead of using drugs or surgery. Therefore, it has the potential to completely treat genetic disorders.

2. Growing investments in pharmaceutical R&D activities are expected to propel the global cell andgene therapy market growth over the forecast period

Key pharmaceutical companies in the market are focused on research and development activities pertaining to gene therapy. Currently, gene therapy is being widely researched for various diseases including cancer, cystic fibrosis, hemophilia, AIDS, and diabetes. For instance, in November 2021, Sio Gene Therapies reported positive interim data for gene therapy trial of Phase I/II of AXO-AAV-GM1 for the treatment of GM1 gangliosidosis, a genetic disorder that progressively destroys nerve cells in the brain and spinal cord.

Market Opportunity

1. Increasing demand for cell and gene therapies can present lucrative growth opportunities

The demand for cell and gene therapies is increasing with growing cases of genetic disorders, chronic diseases, etc. According to the Cystic Fibrosis Foundation (CFF), in the U.S., over 1,000 new cases of cystic fibrosis are diagnosed each year. Moreover, According to the WHO, the number of people with diabetes has increased from 108 million in 1980 to 422 million in 2014. According to the same source, in 2016, around 1.6 million deaths were directly caused due to diabetes. Cell and gene therapies have the potential to treat the aforementioned diseases.

2. Growing regulatory approval can provide major business opportunities

Key companies are focused on research and development activities, in order to gain regulatory approval and enhance market presence. For instance, in March 2021, Celgene Corporation, a subsidiary of Bristol Myers Squibb, received the U.S. Food and Drug Administration (FDA) approval for the first cell-based gene therapy Abecma indicated for the treatment of multiple myeloma.

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Market Trends

1. Stem cell therapy

In the recent past, stem cell therapies have gained significant importance across the healthcare sector. Stem cell therapy has the potential to treat tissue damage and have low immunogenicity. Furthermore, it can enhance the growth of new healthy skin tissues, improve collagen production, stimulate hair development after loss, and can be used in the treatment of various diseases including Parkinson's disease, Alzheimer's disease, cancer, spinal cord injury, etc.

2. North America Trends

Among regions, North America is expected to witness significant growth in the global cell and gene therapy market during the forecast period. This is owing to ongoing clinical trials combined with key companies focusing on R&D activities pertaining to cell and gene therapy. Moreover, the presence of key market players such as Thermo Fisher Scientific, Takara Bio Inc., Catalent Inc., and more are expected to boost the regional market growth in the near future.

Competitive Section

Major companies operating in the global cell and gene therapy market are Thermo Fisher Scientific, Merck KGaA, Lonza, Takara Bio Inc., Catalent Inc., F. Hoffmann-La Roche Ltd, Samsung Biologics, Wuxi Advanced Therapies, Boehringer Ingelheim, Novartis AG, and Miltenyi Biotec.

For instance, in July 2021, Minova Therapeutics Inc. entered into a collaboration and license agreement with Astellas Pharma Inc. for the research, development, and commercialization of novel cell therapy programs for diseases caused by mitochondrial dysfunction.

Global cell and gene therapy Market, By Region:

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Cell and Gene Therapy Market to reach US$ 47,095.2 Mn by end of 2028, Says Coherent Market Insights - PRNewswire

J Vasc Surg. 2021 Nov 14:S0741-5214(21)02437-X. doi: 10.1016/j.jvs.2021.10.051. Online ahead of print.

ABSTRACT

BACKGROUND: Atherosclerosis obliterans (ASO) is a chronic occlusive arterial disease and the most common type of peripheral arterial disease. Current treatment options like medication and vascularization have limited effects for no-option patients, and stem cell therapy is considered a viable option although its application and efficacy have not been standardized. The objective of this review was to assess the safety and efficacy of autologous stem cell therapy in patients with ASO.

METHODS: We performed a literature search of published RCTs for ASO patients receiving stem cell therapy without a revascularization option. PubMed, Embase, and the Cochrane Library were searched. This study was conducted by a pair of authors independently and audited by a third author. Data were synthesized with a random-effect model.

RESULTS: 630 patients in 12 RCTs were included. The results showed that cell therapy significantly improved total amputation (RR: 0.64, p = 0.004, 95% CI: [0.47, 0.87]), major amputation (RR: 0.69, p = 0.02, 95% CI: [0.50, 0.94]), ankle-brachial index (ABI) (MD = 0.08, p = 0.004, 95% CI: [0.02, 0.13]), transcutaneous oxygen tension (TcO2) (MD = 11.52, p = 0.004, 95% CI: [3.60, 19.43]) and rest pain score (MD = -0.64, p = 0.007, 95% CI: [-1.10, -0.17]) compared to placebo or standard care. However, current studies showed cell therapy was not superior to placebo or standard care in all-cause death (RR: 0.75, p = 0.34, 95% CI: [0.41, 1.36]) and ulcer size (MD = -8.85, p = 0.39, CI: [-29.05,11.36]).

LIMITATION: The number of trials included was limited. Moreover, most trials were designed for no-option patients and thus the results should be applied with caution to other PAD patients.

CONCLUSION: ASO patients can benefit from autologous cell therapy in limb salvage, limb blood perfusion, and rest pain alleviation.

PMID:34788653 | DOI:10.1016/j.jvs.2021.10.051

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A Meta-Analysis of Randomized Controlled Trials on Therapeutic Efficacy and Safety of Autologous Cell Therapy for Atherosclerosis Obliterans - DocWire...