The Foundation for Orthopaedics and Regenerative Medicine
This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cells for the treatment of Crohn's Disease or Ulcerative Colitis
Studies have shown that stem cell treatment is safe and efficacious for the treatment of Crohn's Disease or Ulcerative Colitis. Patients will receive a single intravenous infusion of cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.
Inclusion Criteria: * Diagnosis of Crohn's disease or Ulcerative Colitis * Understanding and willingness to sign a written informed consent document Exclusion Criteria: * Active infection * Active cancer * Chronic multisystem organ failure * Pregnancy * Clinically significant Abnormalities on pre-treatment laboratory evaluation * Medical condition that would (based on the opinion of the investigator) compromise patient's safety. * Continued drug abuse * Pre-menopausal women not using contraception * Previous organ transplant * Hypersensitivity to sulfur
cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cells
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