Stem Cells - A Repair Strategy in MS

Overview and History

(stem cell research team pictured above)

There is an unmet need to develop therapies aimed at prevention or reversal of progression-related disability. Over the past decade, the Tisch MS stem cell research team led by Dr. Harris and Dr. Sadiq has developed a strategy to promote repair and regeneration in MS utilizing a population of adult stem cells from the bone marrow (mesenchymal stem cell-derived neural progenitors, or MSC-NPs). In 2012, we published a proof-of-concept study demonstrating that multiple doses of MSC-NPs delivered intrathecally in an experimental model of MS resulted in disease amelioration and decreased demyelination. The mechanisms involved in stem cell-mediated repair included creation of a tolerant CNS milieu as well as induction of resident host stem cell progenitors to differentiate (J Neurol. Sci. 2012).

In August 2013, we received FDA approval to move ahead with a Phase I safety and tolerability clinical trial. 20 patients have been enrolled in the trial and are currently receiving three intrathecal doses MSC-NPs derived from their own bone marrow. Each dose is spaced three months apart. Study patients are being closely monitored for safety, tolerability, and efficacy outcomes. This is the only clinical trial of its kind in the United States to test freshly harvested MSC-NPs administered intrathecally in a multiple dosing regimen. Additional details of the clinical trial can be found on clinicaltrials.gov (NCT01933802).

Implications for MS Patients

Results from this study will enable us to determine if this treatment is safe and effective for patients with progressive disease and established disability.  In addition data generated from the phase I trial will lead to an improved strategy for phase II trials.

Tisch MS Research Stem Cell Trial Announcements

An Update on Phase II of the Tisch MSRCNY FDA Approved Stem Cell Clinical Trial

We continue to be getting many inquiries in regards to our Phase II stem cell trial.  We appreciate your interest.  A grant for funding was submitted to the MS Society on October 1st, and we hope to hear back in January 2017.  We are also pursuing alternate funding sources.  Another update will be posted around the holidays. Thank you.

A Statement from Dr. Saud A. Sadiq and the Tisch MS Research Center of New York

We want to thank everyone for the inquiries regarding phase II of our FDA-approved stem cell clinical trial. The phase I trial is near completion, and preliminary data has shown that the treatment may result in reversal of disability in patients with MS. Due to these unprecedented results in phase 1, the FDA advised the Tisch MS Research Center earlier this year that they may begin preparations for a phase II trial. Planning for the phase II clinical trial is well underway. Details of the multi-center trial, including start date, will be announced once regulatory approval has been obtained, and funding has been secured. This notice will be updated as new developments occur.

 

Tisch MSRCNY Completes Treatment Phase of FDA-Approved Phase I Stem Cell Trial for MS

Tisch MSRCNY is excited to announce that as of September 14, 2016, all 20 patients in our FDA approved Phase I stem cell clinical trial have received their final treatment! Results will be analyzed and presented at our annual patient symposium on October 16th, 2016 at the New York Hilton Midtown. We will submit for publication in leading scientific journals in the near future!

 

Stem Cells Show Reversal of Disability in Multiple Sclerosis at the American Academy of Neurology Meeting (AAN) 2016 Annual Meeting

Read Full Press Release:

AAN 2016 press release final.pdf

FDA Advises Tisch MS Research Center To March On: Preparation To Begin for Phase II Of Stem Cell Trial For MS

Read Full Press Release:

Stem Cell Trial Phase II.pdf

Tisch MS Research Center of New York Delivers Additional Encouraging Results On Phase I Study At The International Society For Stem Cell Research Annual Meeting

Read Full Press Release:

Stem Cell Interim Additional Results Sweden.pdf

Tisch MS Research Center Of New York Reports Early Improvement In Stem Cell Trial

Read Full Press Release:

Stem Cell Interim Results.pdf

Tisch MS Research Stem Cell Trial In the News

Dr. Saud A. Sadiq Speaks About the Tisch MSRCNY Stem Cell Trial on NY1 During National MS Awareness Month

See the full interview on NY1 here: http://bit.ly/1RoY0x1

Dr. Sadiq Interviewed on the Joan Hamburg Show

Listen to the full interview here: http://bit.ly/1QGIeMa.

Wheelchair Kamikaze - An Interview with Dr. Sadiq on Phase II of the Stem Cell Trial

http://www.wheelchairkamikaze.com/2016/01/an-interview-with-dr-saud-sadiq-tisch.htm

MStranslates Interview with Dr. Violaine Harris

Dr. Violaine Harris - Senior Research Scientist at Tisch MS Research Center of New York talks to Brett Drummond from MStranslates about the stem cell trial. Watch the interview here: 

http://bit.ly/1TAkgFI

Bioinformant - Stem Cell Therapy Shows Promise for Treatment of MS - Q&A with Dr. Sadiq of Tisch MSRCNY

http://www.bioinformant.com/stem-cell-therapy-shows-promise-for-treatment-of-multiple-sclerosis-dr-sadiq-of-the-tisch-ms-research-center-of-new-york/

View Tisch MS Stem Cell Trail on FOX5 News, The Big Idea:

http://www.fox5ny.com/news/33677697-story

Tisch MSRCNY Stem Cell Research Featured on CBS Evening News

http://www.cbsnews.com/news/ms-patient-to-take-part-in-pioneering-experiment/