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

• Register: ClinicalTrials.gov
• Last refreshed on: 1 May 2023
• Main ID: NCT03822858
• Date of registration: 24/01/2019
• Prospective Registration: No
• Primary sponsor: Tisch Multiple Sclerosis Research Center of New York
• Public title: Expanded Access to Intrathecal Administration of Autologous Mesenchymal Stem Cell-derived Neural Progenitors (MSC-NP) in Progressive Multiple Sclerosis
• Scientific title: Autologous, Bone Marrow-Derived Mesenchymal Stem Cell-Derived Neural Progenitor Cells (MSC-NP), Expanded Ex Vivo; Administered Intrathecally
• Date of first enrolment: January 14, 2019
• Recruitment status: No longer available
• URL: https://clinicaltrials.gov/show/NCT03822858
• Study type: Expanded Access

Countries of recruitment

United States

Contacts

• Name: Saud A Sadiq, MD, FAAN
• Affiliation: Tisch MS Research Center of New York

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: Intrathecal MSC-NP injection

Secondary ID(s)

TISCHMS-MSCNP-003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors