Multiple Sclerosis
Conditions
Keywords
Mesenchymal Stem Cells, Neural Progenitors, Autologous, Bone Marrow, Multiple Sclerosis
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.
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.
Sponsors
Tisch Multiple Sclerosis Research Center of New York
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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
Countries
United States
Contacts
Primary ContactSaud A Sadiq, MD, FAAN
Backup ContactViolaine Harris, PhD
Outcome results
None listed