CTRI/2014/11/005231
Not yet recruiting
Phase 1
Study of Safety, Feasibility and Efficacy of Autologous Mesenchymal Stem Cells in Multiple Sclerosis - SEAMS
Department of Biotechnology0 sites15 target enrollmentTBD
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Department of Biotechnology
- Enrollment
- 15
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Clinically definite MS based on Revised McDonaldâ??s criteria.
- •Relapsing Remitting MS:
- •a. Patients who have a fixed EDSS of 4 (not during a relapse)
- •b. Unresponsive to one or more approved first or second line therapies (interferons, glatiramer acetate, natalizumab, mitoxantrone, methotrexate, azathioprine for more than one year defined as:
- •more than 2 relapses in the preceding one year of therapy.
- •Persisting enhancement on MRI done within last one year.
- •1 point increase in EDSS over one year.
- •c. Failure or Intolerance to first line DMTs (interferon beta and glatiramer acetate).
- •d. Inability to afford DMT and failure to respond to oral immunosuppressive therapy with methotrexate and azathioprine.
- •Secondary Progressive MS not responding to approved therapy and evidenced by progression of the disease with moderate to severe relapse with an increase of EDSS of 1 point if baseline EDSS less than 5 Or 0\.5 points if baseline EDSS more than 5 at baseline within a year; and or worsening MRI lesion load (equal to 2 enhancing lesions in the last 12 months.
Exclusion Criteria
- •active infection
- •immunocompromised states
- •neoplastic diseases
- •history or laboratory results indicative of any significant cardiac, endocrinological metabolic hematologic and immunologic diseases.
- •Patients who have received natalizumab or fingolimod within last 3 months
- •Patients who had received glatiramer acetate orinterferons within last two months
- •Female patients with known pregnancy or at risk of being pregnant
Outcomes
Primary Outcomes
Not specified
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