Expanded Access to Intrathecal Administration of Autologous Mesenchymal Stem Cell-derived Neural Progenitors (MSC-NP) in Progressive Multiple Sclerosis
Autologous, Bone Marrow-Derived Mesenchymal Stem Cell-Derived Neural Progenitor Cells (MSC-NP), Expanded Ex Vivo; Administered Intrathecally
1 other identifier
expanded_access
N/A
1 country
1
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.
Trial Health
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 24, 2019
CompletedFirst Posted
Study publicly available on registry
January 30, 2019
CompletedAugust 17, 2025
August 1, 2025
January 24, 2019
August 13, 2025
Conditions
Keywords
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tisch MS Research Center of New York
New York, New York, 10019, United States
Related Publications (1)
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.
PMID: 29449193BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Saud A Sadiq, MD, FAAN
Tisch MS Research Center of New York
Central Study Contacts
Study Design
- Study Type
- expanded access
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2019
First Posted
January 30, 2019
Last Updated
August 17, 2025
Record last verified: 2025-08