Expanded Access to Intrathecal Administration of Autologous Mesenchymal Stem Cell-derived Neural Progenitors (MSC-NP) in Progressive Multiple Sclerosis
Primary Purpose
Multiple Sclerosis
Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
Intrathecal MSC-NP injection
Sponsored by
About this trial
This is an expanded access trial for Multiple Sclerosis focused on measuring Mesenchymal Stem Cells, Neural Progenitors, Autologous, Bone Marrow, Multiple Sclerosis
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of MS as defined by the McDonald criteria
- Diagnosis of primary progressive or secondary progressive MS
- Patients will be 18 years or older
- Significant disability shown by an Expanded Disability Status Score (EDSS, [5]) ≥4.5 that was not acquired within the last 12 months *(Patients with moderate to severe cerebellar dysfunction who have an EDSS of <6.5 who are not eligible for our Ph II Version Date: 11/21/18 Version #4 9 study will be included. This is because EDSS scores are heavily related to muscle strength and not balance or coordination and most accurately reflect paraparesis. Also there are patients with MS who have disabling upper limb coordination dysfunction but EDSS scores of better than 6.5 who are not suitable for the Phase II study but may benefit from this therapy).
- Stable disease state as evidenced by a lack of gadolinium-enhancing lesions on an MRI and by a stable MRI disease burden (number of T2 lesions and size of lesions) in the last six months and no significant change in EDSS (1 point or more) in the last 12 months
- Does not qualify for the inclusion/exclusion criteria of our Phase II stem cell trial. For example, patients with EDSS >6.5 or MS symptom onset and/or duration of disease >15 years
Exclusion Criteria:
- All patients who have had any prior stem cell treatments, including HSCT
- Pregnant or nursing mothers or any woman intending to become pregnant in the next three years
- Use of systemic chemotherapeutic or anti-mitotic medications within three months of study start date due to the possibility of interference with bone marrow procedure
- History of central nervous system infection or immunodeficiency syndromes due to increased risk of CNS infection
- Patients who are anticipated to have difficultly accessing the intrathecal space related to scoliosis, obesity, or any other relevant factors determined by the PI.
- Patients who have not tried available therapies for their progressive MS
Sites / Locations
- Tisch MS Research Center of New York
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT03822858
First Posted
January 24, 2019
Last Updated
April 18, 2023
Sponsor
Tisch Multiple Sclerosis Research Center of New York
1. Study Identification
Unique Protocol Identification Number
NCT03822858
Brief Title
Expanded Access to Intrathecal Administration of Autologous Mesenchymal Stem Cell-derived Neural Progenitors (MSC-NP) in Progressive Multiple Sclerosis
Official Title
Autologous, Bone Marrow-Derived Mesenchymal Stem Cell-Derived Neural Progenitor Cells (MSC-NP), Expanded Ex Vivo; Administered Intrathecally
Study Type
Expanded Access
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tisch Multiple Sclerosis Research Center of New York
4. Oversight
5. Study Description
Brief Summary
To give expanded access to intrathecal autologous MSC-NP treatment to patients with progressive MS who do not meet the inclusion/exclusion criteria of our Phase II stem cell trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Mesenchymal Stem Cells, Neural Progenitors, Autologous, Bone Marrow, Multiple Sclerosis
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Intrathecal MSC-NP injection
Intervention Description
Between 5 to 10 million MSC-NPs will be administered intrathecally in each dose.
10 million cells is the maximum dose. Treatment will consist of 3-5 doses spaced 3 months apart.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Eligibility Criteria
Inclusion Criteria:
Diagnosis of MS as defined by the McDonald criteria
Diagnosis of primary progressive or secondary progressive MS
Patients will be 18 years or older
Significant disability shown by an Expanded Disability Status Score (EDSS, [5]) ≥4.5 that was not acquired within the last 12 months *(Patients with moderate to severe cerebellar dysfunction who have an EDSS of <6.5 who are not eligible for our Ph II Version Date: 11/21/18 Version #4 9 study will be included. This is because EDSS scores are heavily related to muscle strength and not balance or coordination and most accurately reflect paraparesis. Also there are patients with MS who have disabling upper limb coordination dysfunction but EDSS scores of better than 6.5 who are not suitable for the Phase II study but may benefit from this therapy).
Stable disease state as evidenced by a lack of gadolinium-enhancing lesions on an MRI and by a stable MRI disease burden (number of T2 lesions and size of lesions) in the last six months and no significant change in EDSS (1 point or more) in the last 12 months
Does not qualify for the inclusion/exclusion criteria of our Phase II stem cell trial. For example, patients with EDSS >6.5 or MS symptom onset and/or duration of disease >15 years
Exclusion Criteria:
All patients who have had any prior stem cell treatments, including HSCT
Pregnant or nursing mothers or any woman intending to become pregnant in the next three years
Use of systemic chemotherapeutic or anti-mitotic medications within three months of study start date due to the possibility of interference with bone marrow procedure
History of central nervous system infection or immunodeficiency syndromes due to increased risk of CNS infection
Patients who are anticipated to have difficultly accessing the intrathecal space related to scoliosis, obesity, or any other relevant factors determined by the PI.
Patients who have not tried available therapies for their progressive MS
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saud A Sadiq, MD, FAAN
Organizational Affiliation
Tisch MS Research Center of New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tisch MS Research Center of New York
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29449193
Citation
Harris VK, Stark J, Vyshkina T, Blackshear L, Joo G, Stefanova V, Sara G, Sadiq SA. Phase I Trial of Intrathecal Mesenchymal Stem Cell-derived Neural Progenitors in Progressive Multiple Sclerosis. EBioMedicine. 2018 Mar;29:23-30. doi: 10.1016/j.ebiom.2018.02.002. Epub 2018 Feb 3.
Results Reference
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Expanded Access to Intrathecal Administration of Autologous Mesenchymal Stem Cell-derived Neural Progenitors (MSC-NP) in Progressive Multiple Sclerosis
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