CompletedPhase 1/2

Mesenchymal Stem Cells in the Treatment of Relapsed/Refractory Severe Acquired Aplastic Anemia

Brazil9 participantsStarted 2011-02

Plain-language summary

Mesenchymal stem cells have been tested in many autoimmune disorders with encouraging results and may be an alternative to the treatment of immune-mediated severe acquired aplastic anemia.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of Acquired Aplastic Anemia * Relapse/refractory to at least 1 immunosuppressive first line treatment * Not eligible to allogeneic bone marrow transplantation Exclusion Criteria: * Previous or current malignancy * Active or latent infectious disease * Positive serologic tests for HIV, HCV, HBV, HTLV-1 and 2, Syphilis or Chagas disease * Previous drug reaction for antithymocyte globulin, cyclosporin or corticosteroids * Severe organic impairment (renal, hepatic, cardiac, pulmonary) * Uncontrolled hypertension or diabetes * Pregnancy * Previous history of allergic reaction to penicillin or streptomycin * Severe psychiatric disorder

What they're measuring

Number of Participants with Adverse Events as a Measure of Safety and Tolerability of intravenous allogeneic unrelated mesenchymal stem cells infusion in patients with severe acquired aplastic anemia.

Timeframe: After the mesenchymal stem cells infusion up to 6 mounth after

Trial details

NCT IDNCT01297972

SponsorUniversity of Sao Paulo

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-11

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