Mult Scler Relat Disord. 2015 Mar;4(2):159-69. doi: 10.1016/j.msard.2015.01.005. Epub 2015 Jan 24.
High doses of biotin in chronic progressive multiple sclerosis: a pilot study.
Sedel F1, Papeix C2, Bellanger A3, Touitou V4, Lebrun-Frenay C5, Galanaud D6, Gout O7, Lyon-Caen O2, Tourbah A8.
Author information
Abstract
BACKGROUND:
No drug has been found to have any impact on progressive multiple sclerosis (MS). Biotin is a vitamin acting as a coenzyme for carboxylases involved in key steps of energy metabolism and fatty acids synthesis. Among others, biotin activates acetylCoA carboxylase, a potentially rate-limiting enzyme in myelin synthesis.

OBJECTIVES:
The aim of this pilot study is to assess the clinical efficacy and safety of high doses of biotin in patients suffering from progressive MS.

STUDY DESIGN:
Uncontrolled, non-blinded proof of concept study

METHODS:
23 consecutive patients with primary and secondary progressive MS originated from three different French MS reference centers were treated with high doses of biotin (100-300mg/day) from 2 to 36 months (mean=9.2 months). Judgement criteria varied according to clinical presentations and included quantitative and qualitative measures.

RESULTS:
In four patients with prominent visual impairment related to optic nerve injury, visual acuity improved significantly. Visual evoked potentials in two patients exhibited progressive reappearance of P100 waves, with normalization of latencies in one case. Proton magnetic resonance spectroscopy (H-MRS) in one case showed a progressive normalization of the Choline/Creatine ratio. One patient with left homonymous hemianopia kept on improving from 2 to 16 months following treatment׳s onset. Sixteen patients out of 18 (89%) with prominent spinal cord involvement were considered as improved as confirmed by blinded review of videotaped clinical examination in 9 cases. In all cases improvement was delayed from 2 to 8 months following treatment׳s onset.

CONCLUSIONS:
These preliminary data suggest that high doses of biotin might have an impact on disability and progression in progressive MS. Two double-blind placebo-controlled trials are on going.

Copyright © 2015 The Authors. Published by Elsevier B.V. All rights reserved.

KEYWORDS:
Biotin; Multiple sclerosis; Optic neuritis; Progressive; Visual evoked potentials

“To a classically trained surgeon the use of biologics such as bone marrow stem cells and amniotic membrane sounds like witchcraft. After you study it you realize the cells and growth factors from the biologics are the way the body normally heals itself. The surgery is the witchcraft.” Dr. Wade McKenna at lunch yesterday. www.rmiclinic.com

Biologic augmentation of rotator cuff repair with mesenchymal stem cells during arthroscopy improves healing and prevents further tears: a case-controlled study.
PMID: 24913770

Abstract
Purpose The purpose of this study was to evaluate the efficiency of biologic augmentation of rotator cuff repair with iliac crest bone marrow-derived mesenchymal stem cells (MSCs). The prevalence of healing and prevention of retears were correlated with the number of MSCs received atthe tendon-to-bone interface. Methods Forty-five patients in the study group received concentrated bone marrow-derived MSCs as an adjunct to singlerow rotator cuff repair at the time of arthroscopy. The average number of MSCs returned to the patient was 51,000±25,000. Outcomes of patients receiving MSCs during their repair were compared to those of a matched control group of 45 patients who did not receive MSCs. All patients underwent imaging studies of the shoulder with iterative ultrasound performed every month from the first postoperative month to the 24th month. The rotator cuff healing or re-tear was confirmed with MRI postoperatively at three and six months, one and two years and at the most recent follow up MRI (minimum ten-year follow-up). Results Bone marrow-derived MSC injection as an adjunctive therapy during rotator cuff repair enhanced the healing rate and improved the quality of the repaired surface as determined by ultrasound and MRI. Forty-five (100 %) of the 45 repairs with MSC augmentation had healed by six months, versus 30 (67 %) of the 45 repairs without MSC treatment by six months. Bone marrow concentrate (BMC) injection also prevented further ruptures during the next ten years. At the most recent follow-up of ten years, intact rotator cuffs were found in 39 (87 %) of the 45 patients in the MSC-treated group, but just 20 (44 %) of the 45 patients in the control group. The number of transplanted MSCs was determined to be the most relevant to the outcome in the study group, since patients with a loss of tendon integrity at any time up to the ten-year follow-up milestone received fewer MSCs as compared with those who had maintained a successful repair during the same interval.
Conclusion This study showed that significant improvement in healing outcomes could be achieved by the use of BMC containing MSC as an adjunct therapy in standard of care rotator cuff repair. Furthermore, our study showed a substantial improvement in the level of tendon integrity present at the ten-year milestone between the MSC-treated group and the control patients. These results support the use of bone marrow derived MSC augmentation in rotator cuff repair, especially due to the enhanced rate of healing and the reduced number of re-tears observed over time in the MSC-treated patients.

From Conclusions
For patients who received MSCs of the footprint there was a negative correlation between the time to obtain total healing of a same surface and the concentration of MSCs in the graft (Rs= –0.4; p=0.04). Size of the tear also had a significant relation (p=0.03) with time to healing, i.e. patients in the MSC-treatment group with tears larger than 2 cm needed a longer time to reach total healing (average six months) compared to the patients with tears smaller than 2 cm (average three months). Regardless of the size of the tear, patients in the control group took two months longer to reach total healing when matched for tear size compared to the patients in the MSC-treatment group.

From a schematic point of view, patients who received more than 30,000 MSCs had healed 2 cm² or more over the footprint at three months, while those who received fewer than 30,000 MSCs needed at least four months or more to achieve the same degree of surface healing. For control group patients, none had achieved healing of 2 cm² at three months, but required on average six months for surface healing to reach 2 cm.

Note: The authors used colony forming units (10 days of culture) to determine the number of mesenchymal stem cells, not simple counting of cells on flow cytometer.

After FDA Approval, Duchenne’s Muscular Dystrophy Patient Receives First Umbilical Cord Stem Cell Treatment in the United States

Ryan Benton, a 28 year-old Duchenne’s muscular dystrophy patient from Wichita, Kansas, received his first umbilical cord tissue-derived mesenchymal stem cell treatment yesterday following US FDA approval of his doctor’s application for a single patient, investigational new drug (IND) for compassionate use.

Duchenne muscular dystrophy (DMD) is a rapidly progressive form of muscular dystrophy that occurs primarily in boys. It is caused by an alteration (mutation) in a gene, called the DMD gene, which causes the muscles to stop producing the protein dystrophin. Individuals who have DMD experience progressive loss of muscle function and weakness, which begins in the lower limbs and leads to progressively worsening disability. Death usually occurs by age 25, typically from lung disorders. There is no known cure for DMD.

This trial, officially entitled “Allogeneic transplantation of human umbilical cord mesenchymal stem cells (UC-MSC) for a single male patient with Duchenne Muscular Dystrophy (DMD)” marks the first time the FDA has approved an investigational allogeneic stem cell treatment for Duchenne’s in the United States.

Ryan received his first intramuscular stem cell injections from allergy and immunology specialist, Van Strickland, M.D at Asthma and Allergy Specialists in Wichita, Kansas. He will receive 3 more treatments this week on consecutive days. Dr. Strickland will administer similar courses to Ryan every 6 months for a total of 3 years.

This is not the first time Ryan has undergone umbilical cord mesenchymal stem cell therapy. Since 2009, Ryan has been traveling to the Stem Cell Institute in Panama for similar treatments. Encouraging results from these treatments prompted Dr. Strickland to seek out a way to treat Ryan in the United States.

The stem cell technology being utilized in this trial was developed by renowned stem cell scientist Neil H. Riordan, PhD. Dr. Riordan is the founder and president of the Stem Cell Institute in Panama City, Panama and Medistem Panama. Medistem Panama is providing cell harvesting and banking services for their US-based cGMP laboratory partner.

Funding for this trial is being provided by the Aidan Foundation, a non-profit organization founded by Dr. Riordan in 2004 to provide financial assistance for alternative therapies to people like Ryan.

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