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

Study Overview
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Brief Summary
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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.

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

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: Intrathecal MSC-NP injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Intrathecal MSC-NP injection|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bone Marrow, Mesenchymal Stem Cells, Autologous, Neural Progenitors, Multiple Sclerosis