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