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Study finds stem cells for stroke safe & effective

Louis A. Cona, MD

Nov 19, 2019

New study has found mesenchymal stem cells to be both a safe and effective treatment option for stroke.

Stroke is one of the leading causes of human disability in North America. It is also the leading cause of neurological damage resulting in loss of quality of life or disability-adjusted years.  More than 140,000 people die from stroke in the United States every year, with thousands more surviving with lasting neurological damage.  These neurological damages can limit one's ability to speak, move and support oneself.  There are many different types of therapies looking to assist with post-stroke recovery, such as; physiotherapy, mobility training, motor-skill exercises and range of motion therapies.  These focus on improving neural processes, mobility, and behavioral attributes.

Intravenous Allogeneic Mesenchymal Stem Cells for Stroke

A new study conducted by Michael Levy and colleagues has found the intravenous injection of allogeneic mesenchymal stem cells to be both a safe and effective treatment option for post-stroke long term recovery.  

The randomized, placebo-controlled study, published by the University of California enrolled 36 subjects who had experienced an Ischemic stroke >6 months before the date of study enrollment.  The study criteria also required that patients have no substantial improvement in neurological or functional status for 2 months before study enrollment. 

The safety portion of the study was split into 2 parts, each increasing the cell dosage upon completion of previous findings.  The maximum dosage was 150 million mesenchymal stem cells, as per the studies part 1 findings of established safety with 1.5 million cells/kg of body weight.  The parent cell bank had been tested for quality control including; cell count, viability (are the cells alive), appearance and viruses.


According to Michael Levy and colleagues:


"The primary study endpoint was safety and tolerability, evaluated in all subjects who received any portion of an infusion, and determined by the incidence/severity of adverse events, clinically significant changes on laboratory and imaging tests, vital signs, and physical plus neurological examinations. Four secondary endpoints were scored serially to derive preliminary estimates of efficacy: National Institutes of Health Stroke Scale, Barthel Index (BI), Mini-Mental Status Exam, and Geriatric Depression Scale. For each, the change from baseline was evaluated using Wilcoxon signed-rank test, with primary analysis of preliminary efficacy being change from baseline to 6 months post-infusion, and analysis including all subjects who received an infusion except for one subject who failed to return after the day 10 visit for all visits (except for month 9 follow-up)." (1)


Study participant safety

Testing disclosed no safety concerns among participants.  There we no positive reactions to intradermal testing (allergy testing).  There were no significant findings after follow up physical examinations and blood testing.  


Subject behavioral improvements

"Across all subjects, improvements were seen in National Institutes of Health Stroke Scale, BI, Mini-Mental Status Exam, and Geriatric Depression Scale scores at both the 6-month and the 12-month follow-up visits." (1)


These were all found to be statistically significant, changes in the Barthel score ( a scale used to measure performance in daily living activities) increased from 11.4% at baseline (pre-treatment) to 35.5% improvement at 12 months post-treatment. This study showed that Mesenchymal stem cells can be a safe treatment for stroke that is potentially associated with functional improvements.  


"Intravenous infusion of MSC was found to be safe in 36 patients who had chronic stroke with substantial functional deficits. Across 3 escalating doses, treatment-related adverse events were infrequent, mild, and transient. Serial assessments of exam, laboratory testing, electrocardiogram, and CT scans of chest/abdomen/pelvis disclosed no safety concerns, with limited subject dropout. These results are consistent with the overall excellent safety record that MSC has in clinical trials of human subjects across numerous non-cerebrovascular diagnoses 15, 24–27 and in stroke trials." (1)


Conclusion

This is the largest study to assess the effects of intravenous MSCs in patients with chronic stroke. What we found quite impressive with this study is that patients with chronic stroke typically show functional decline. However, the study found that patients treated with MSCs experienced functional improvement over the course of 12 months.  These findings showed that even after 12 months post-treatment MSCs still had broad effects on brain function.  Levy and colleagues also state that paired with a functional restorative therapy approach these cognitive improvements could provide maximum benefit, as opposed to MSC infusion alone.


References:

  1. Levy, Michael L., et al. “Phase I/II Study of Safety and Preliminary Efficacy of Intravenous Allogeneic Mesenchymal Stem Cells in Chronic Stroke.” Stroke, vol. 50, no. 10, 2019, pp. 2835–2841., doi:10.1161/strokeaha.119.026318.

3 DAYS POST TREATMENT

Tyler explains his experience at DVC Stem in the Cayman Islands.

Tyler is optimistic that he will see positive results post treatment.

"The cool thing about the Cayman Islands besides being beautiful, it was an opportunity to get some rest and relaxation allowing my body to heal and restore. I'm back in the US now and feel like I am ready to conquer the world."

- Tyler Heid

2 WEEKS POST TREATMENT

2 weeks post treatment, MS patient Tyler is beginning to see amazing progress. He has been wheelchair bound for the last year and has not been able to move his legs unassisted before now.

Tyler Heid, lifting his foot 12" off the ground with 2 lb weights on his ankles.

Tyler - 2 weeks post treatment

"I'm on a path of progression and I'm getting better and better each day."

Tyler Heid - 2 months post treatment

2 MONTHS POST TREATMENT

Tyler updates about his progress, explaining the amazing response he has been receiving from his friends and family.

"People coming up to me saying I am moving, talking and smiling so much better. They are noticing a lot of things that have improved over the course of 3 months."

"This morning I was able to do things that I was unable to do before, I was able to stand up and lift my leg higher than I ever have before."

5 MONTHS POST TREATMENT

5 months post treatment Tyler sends us an update on his progress.

"I'm able to smile better, I have more control over the left side of my face."

"I have an increased ability to grip, lift my legs higher and higher which has gone well."

Tyler is optimistic and on the right track to recovery. We are ecstatic to see his progress and look forward to more updates from him.

"I have an increased ability to grip, lift my legs higher and higher which has gone well."

Tyler Heid - 5 months post treatment

"This is exciting stuff, god bless"

Matthew Murry - MS Patient

2 WEEKS POST TREATMENT

Matthew experiences sensation in the bottom of his feet after receiving a simple nerve test.

His left foot did not experience any sensation or move at all, but what happened to his right foot is extremely exciting!

David Lyons

Multiple Sclerosis

Although David Lyons was able to successfully fight Multiple Sclerosis through a strict regimen of diet and exercise, he wanted to ensure he was doing everything he could to stay fit. Multiple Sclerosis can be managed with treatment, but there is currently no cure for the disease. For that reason, David came to DVC Stem years ago to use the regenerative and anti-inflammatory attributes of stem cells to aid in his fight for fitness.

The positive results he experienced enabled David to stay strong in the gym, now into his 60s, and that is why he continues to support our clinic to this day.

About the author

LOUIS A. CONA, MD

Dr. Cona has been performing stem cell therapy for over 10 years. He is a member of the World Academy of Anti-Aging Medicine (WAAAM). He is also a recognized member of the British Medical Association, the General Medical Council (UK), the Caribbean College of Family Physicians, and the American Academy of Family Physicians. He is the Medical Director for DVC Stem a world-renowned stem cell therapy clinic located in Grand Cayman.

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