Health Condition 1: null- Multiple Sclerosis
Conditions
Interventions
Intervention1: Mesenchymal stem cells: Culturing of cells would approximately take 3 weeks which will be a sterile procedure in GMP certified lab.There is no manipulation done in culturing the cells a
Sponsors
Department of Biotechnology
Eligibility
Inclusion 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. Primary Progressive MS: 6 months to one year of active disease progression as documented by worsening EDSS of of 1 point if baseline EDSS less than or equal to 5 OR 0.5 points if baseline EDSS is more than 5 at baseline within a year Expanded disability status scale (EDSS) score of between 3-7 at screening evaluation. Able to give written informed consent.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety and efficacy end points. The safety end points would include measurement of serious adverse events i.,e mortality, occurrence of relapse (number and frequency of events). Laboratory assessments like complete hemogram, liver and kidney function tests, immunology profile : C3 , IgA IgMTimepoint: day 2, one week, 3, 6 and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| clinical and radiological assessments. clinical: visual function tests, progression of disability on EDSS, MSFC, Scripps neurological scale, SF36 questionnaire. Radiological assessment : the number of CET lesions on T2 MRI, The number of T1 hypo intense lesions from baseline to follow upTimepoint: day2, one week, 3,6 and 12 months | — |
Countries
India
Contacts
Public ContactDr Rohit Bhatia
All India Institute of Medical Sciences
Outcome results
None listed