Intrathecal Administration of Autologous Mesenchymal Stem Cell-derived Neural Progenitors (MSC-NP) in Patients With Multiple Sclerosis
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|ClinicalTrials.gov Identifier: NCT01933802|
Recruitment Status : Completed
First Posted : September 2, 2013
Last Update Posted : March 19, 2018
|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|
|Actual Primary Completion Date :||December 2016|
|Actual 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|