Expanded Access to Intrathecal Administration of Autologous Mesenchymal Stem Cell-derived Neural Progenitors (MSC-NP) in Progressive Multiple Sclerosis

August 13, 2025 updated by: Tisch Multiple Sclerosis Research Center of New York

Autologous, Bone Marrow-Derived Mesenchymal Stem Cell-Derived Neural Progenitor Cells (MSC-NP), Expanded Ex Vivo; Administered Intrathecally

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.

Study Overview

Status

Available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Treatment IND/Protocol

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10019
        • Available
        • Tisch MS Research Center of New York

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tisch Multiple Sclerosis Research Center of New York

Investigators

  • Principal Investigator: Saud A Sadiq, MD, FAAN, Tisch MS Research Center of New York

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

January 24, 2019

First Submitted That Met QC Criteria

January 29, 2019

First Posted (Actual)

January 30, 2019

Study Record Updates

Last Update Posted (Actual)

August 17, 2025

Last Update Submitted That Met QC Criteria

August 13, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TISCHMS-MSCNP-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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