Proposal for a Non-randomized, Patient Sponsored, Multi-center Study Studying the Impact and Safety of the Utilization of Culture Expanded Autologous, Adipose-derived Mesenchymal Stem Cells Deployed Via Intravenous Injection for the Treatment of Multiple Sclerosis

NCT02326935 Phase 1 TERMINATED

The intent of this clinical study is to answer the questions: 1) is the proposed treatment safe and 2) is treatment effective in improving the disease pathology of patients with Multiple Sclerosis and clinical outcomes.

Details

Lead sponsor	American CryoStem Corporation
Phase	Phase 1
Status	TERMINATED
Enrolment	2
Start date	2014-11
Completion	2018-05-18

Conditions

• Multiple Sclerosis

Interventions

• Autologous adipose derived mesenchymal cells

Primary outcomes

• Standard Complication Questionnaire — 3 months
  incidence and nature of adverse events, serious adverse events, or any unanticipated adverse events. The nature, incidence, and rate of adverse events will be assessed
• MS Impact Scale - MSIS-29 — 3 months
  Multiple Sclerosis Impact Scale (MSIS-29)
• Modified SF-36 Cell-Based Therapy Follow Up — 3 months
  Modified SF-36 for Cell-Based Therapy Follow Up
• Physical Evaluation — 3 Months
  Vital signs of sitting blood pressure, temperature and heart rate

Countries

Cayman Islands