Ignite Creation Date:
2024-05-06 @ 10:47 AM
Last Modification Date:
2024-10-26 @ 12:35 PM
Study NCT ID:
NCT03355365
Status:
COMPLETED
Last Update Posted:
2024-04-12
First Post:
2017-11-14
Brief Title:
Intrathecal Administration of Autologous Mesenchymal Stem Cell-derived Neural Progenitors MSC-NP in Progressive Multiple Sclerosis
Sponsor:
Tisch Multiple Sclerosis Research Center of New York
Organization:
Tisch Multiple Sclerosis Research Center of New York
Study Overview
Official Title:
Autologous Bone Marrow-Derived Mesenchymal Stem Cell-Derived Neural Progenitor Cells MSC-NP Expanded Ex Vivo Administered Intrathecally
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase II double-blinded placebo-controlled randomized cross-over Study designed to determine the efficacy of multiple intrathecal administrations of autologous mesenchymal stem cell-derived neural progenitor cells MSC-NP compared to placebo in patients with progressive multiple sclerosis Efficacy will be measured through assessment of disability outcomes Study participants will receive six intrathecal injections of culture-expanded autologous MSC-NPs at two month intervals in one year and six lumbar punctures as placebo treatments in a second year
Detailed Description:
The IT-MSC-NP treatments and all clinical assessments will take place at a single center Tisch MSRCNY Study subjects will be assigned to blocks stratified by baseline EDSS score 30-40 45-55 60 and 65 and disease subtype SPMS or PPMS Study subjects are randomized in an equal fashion 11 to study treatment and placebo at initial randomization Subjects in each block will be randomized into placebo or treatment group In the second year treated subjects will cross over to the placebo group and placebo subjects will cross over to the treated group
The total study duration will be 3 years upon enrollment Each study subject will be required to attend up to 18 study visits to include 1 screening visit 1 bone marrow visit 1 baseline visit followed by study visits every 2 months during the treatment period of two years 12 treatmentLP procedure visits and 2 outcome visits and an additional follow-up visit at the end of year 3
The total study duration will be 3 years upon enrollment Each study subject will be required to attend up to 18 study visits to include 1 screening visit 1 bone marrow visit 1 baseline visit followed by study visits every 2 months during the treatment period of two years 12 treatmentLP procedure visits and 2 outcome visits and an additional follow-up visit at the end of year 3
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None