Intrathecal Administration of Autologous Mesenchymal Stem Cell-derived Neural Progenitors (MSC-NP) in Patients With Multiple Sclerosis
|ClinicalTrials.gov Identifier: NCT01933802|
Recruitment Status : Completed
First Posted : September 2, 2013
Last Update Posted : October 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Biological: intrathecal administration of autologous MSC-NP||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1 Safety Study of Autologous Bone Marrow-derived Mesenchymal Stem Cell-derived Neural Progenitor Cells (MSC-NP), Expanded Ex Vivo, Administered Intrathecally in Patients With Multiple Sclerosis|
|Study Start Date :||April 2014|
|Primary Completion Date :||December 2016|
|Study Completion Date :||March 2017|
Experimental: autologous MSC-NP
intrathecal administration of autologous MSC-NP in three doses at three month intervals
Biological: intrathecal administration of autologous MSC-NP
Autologous MSC-NPs administered intrathecally at a dose between 2 and 10 million cells, depending on ex vivo expansion characteristics. Three doses will be administered at 3 month intervals.
- Number of participants with adverse events [ Time Frame: 9 months ]The primary objective of the study is to assess the safety and tolerability of intrathecal therapy with autologous MSCNPs in MS. Number of participants with adverse events will be documented 1 day, 1 week, 1 month and 2 months post treatment for three treatments (followup for third treatment is 3 months instead of 2 months).
- Number of participants with adverse events . [ Time Frame: 30 months ]The co-primary objective will be to observe long term safety of the treatment 6 months and 30 months following the last treatment.
- Preliminary evaluation of efficacy [ Time Frame: 9 months ]The secondary objective is to observe trends in efficacy over the course of the experimental treatment. Outcome measures include evoked potentials (baseline and 3 months post 3rd dose) ,quality of life questionnaire, EDSS, and MSFC (baseline, at the time of each dose, and 3 and 6 months after third dose), and MRI (baseline, 2 months after first dose, and 3 and 24 months after third dose).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01933802
|United States, New York|
|Tisch MS Research Center of New York|
|New York, New York, United States, 10019|
|Principal Investigator:||Saud A Sadiq, MD||Tisch MS Research Center of New York|