Clinical Trial: Treatment of Refractory Sever Systemic Scleroderma by Injection of Allogeneic Mesenchymal Stem Cells
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Treatment of Refractory Sever Systemic Scleroderma by Injection of Allogeneic Mesenchymal Stem Cells
Brief Summary: The main ailm of this phase I-II study is to evaluate toxicity and efficacy of allogenic mesenchymal stem cell therapy to treat severe systemic sclerosis. In practice this treatment will be given to patients with a rapidly evolutive disease or refractory to cyclophosphamide.
Detailed Summary:
Sponsor: Assistance Publique - Hôpitaux de Paris
Current Primary Outcome: toxicity [ Time Frame: 2 years ]
All grade 3 or above toxicity base on the CTCAE - Cancer Therapy Evaluation Program (CTEP), observed during the 2 years of follow up.
(http://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/ctcaev3.pdf)
Original Primary Outcome: Same as current
Current Secondary Outcome:
- survival [ Time Frame: 2 years ]
- progression free survival [ Time Frame: 2 years ]
- Rodnan score [ Time Frame: 2 years ]
- Clinical response [ Time Frame: 3, 6, 9, 12 months ]Observed clinical response and efficiency in the scalability of SSc: 3, 6, 9 and 12 months after the procedure.
Original Secondary Outcome: Same as current
Information By: Assistance Publique - Hôpitaux de Paris
Dates:
Date Received: July 17, 2014
Date Started: June 2014
Date Completion: June 2019
Last Updated: April 15, 2016
Last Verified: April 2016