Stem Cell injection in Multiple Sclerosis patients

Phase 1

• Conditions: Health Condition 1: null- Multiple Sclerosis

• Registration Number: CTRI/2014/11/005231
• Lead Sponsor: Department of Biotechnology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 15

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified