drugset / Trial / NCT01485198

Autologous Stem Cells in Osteoarthritis

NCT01485198

Phase 1 Completed 61 enrolled Hospital Universitario Dr. Jose E. Gonzalez
RandomizedParallel-groupOpen-labelTreatment

Summary

Patients with osteoarthritis, a degenerative joint disease, that meet inclusion criteria will be allocated into two groups: * The control group will receive Acetaminophen 750mg orally every 8 hours * The experimental group will receive Autologous Hematopoietic Stem Cells from bone marrow (BMASC) Signed informed consent is required, as well as answering a questionnaire. Patients in experimental group will receive subcutaneous G-CSF (10ug/kg/day) for 3 consecutive days and, on the 4th day a bone marrow harvest under general sedation will be performed from posterior iliac crests. The patient will remain in the recovery room while the cells are processed at the Hematology Service Laboratory. Finally, BMASC will be infused to the joint under local anesthesia. The procedure is ambulatory.

Timeline

Start
2011-08
Primary completion
2013-08
Completion
2014-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Acetaminophen Small molecule 750 mg Oral

Indications