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A phase IIb double blind trial to investigate the efficacy and the optimal way of administration of mesenchymal stem cells (MSC) in active and progressive multiple sclerosis (MS)
Author(s): ,
P. Petrou
Affiliations:
Multiple Sclerosis and Neuroimmunology Unit, Neurology Department, Hadassah University Hospital, Jerusalem, Israel
,
I. Kassis
Affiliations:
Multiple Sclerosis and Neuroimmunology Unit, Neurology Department, Hadassah University Hospital, Jerusalem, Israel
,
N. Levin
Affiliations:
Multiple Sclerosis and Neuroimmunology Unit, Neurology Department, Hadassah University Hospital, Jerusalem, Israel
,
P. Friedmann
Affiliations:
Neurology Department, Charite University, Berlin, Germany
,
M. Scheel
Affiliations:
Neurology Department, Charite University, Berlin, Germany
,
F. Oertel
Affiliations:
Neurology Department, Charite University, Berlin, Germany
,
M. Hallimi
Affiliations:
Multiple Sclerosis and Neuroimmunology Unit, Neurology Department, Hadassah University Hospital, Jerusalem, Israel
,
T. Ben Hur
Affiliations:
Multiple Sclerosis and Neuroimmunology Unit, Neurology Department, Hadassah University Hospital, Jerusalem, Israel
,
A. Ginzberg
Affiliations:
Multiple Sclerosis and Neuroimmunology Unit, Neurology Department, Hadassah University Hospital, Jerusalem, Israel
D. Karussis
Affiliations:
Multiple Sclerosis and Neuroimmunology Unit, Neurology Department, Hadassah University Hospital, Jerusalem, Israel
ECTRIMS Online Library. Petrou P. Oct 12, 2018; 228146
Panayiota Petrou
Panayiota Petrou
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Abstract: P1768

Type: Poster Sessions

Abstract Category: N/A

Background: MSC have been shown to possess neurotrophic and neuroprotective effects. Two prior pilot studies in our center showed that a single intrathecal(IT) administration of MSCs was safe and well tolerated, and provided indications of clinical efficacy in MS and ALS.
Objectives: To evaluate the safety and efficacy of transplantation of autologous bone marrow-derived MSC (bmMSC), in MS.
Methods: This is a double-blind crossover trial that enrolled 48 progressive MS-patients from Hadassah MS Center (from February 2015 to June 2018). The mean EDSS at inclusion was 5.6. Patients did not receive any immunomodulatory treatment during the 14 months of the trial. EDSS, walking speed test, 9-hole peg test, neurocognitive evaluation, quantitative and functional MRI, OCT, VEP, and visual functions' assessment in the static and dynamic domains, were performed monthly before the transplantation and at 3 months intervals after the treatment. Patients were randomized and treated with either autologous, bmMSC (1x106/Kg) or placebo, IT or IV. At 6-months the patients were re-treated with a second injection of bmMSC or placebo and followed for safety and all the efficacy measures for additional 6 months. The study was approved by the local Ethics committee and MOH, registered to NIH (NCT02166021) and monitored by an external CRO and an external safety committee.
Results: No serious treatment-related adverse events have been observed during the whole period of the trial. Two patients withdrew from the trial. 22 out of the 48 patients deteriorated in EDSS during the 2 months before the treatment (indicating a group with very active disease). A scheduled interim analysis of the 32 first patients showed a highly significant beneficial effect of the treatment in terms of EDSS progression and a positive trend in terms of the relapses' frequency. The first analysis from all 48 patients is now running and will be presented upon completion.
Conclusion: IT and IM administration of autologous MSCs seems to be well-tolerated. Our trial, uniquely, uses the intrathecal way of administration and for the first time a rigorous double-blind design utilizing extensive surrogate markers to detect possible clinical effects of regeneration. In addition, this study is the first to try to evaluate the optimal way of administration of stem cells in MS and to evaluate the possible additional benefit of a repeated injection.
Disclosure: Nothing to disclosure

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