NCT01485198

Autologous Stem Cells in Osteoarthritis

Clinical Effects of Autologous Bone Marrow Mononuclear Cell Infusion in Knee Osteoarthritis.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Hospital Universitario Dr. Jose E. Gonzalez · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
PROCEDURE	Bone Marrow Autologous Stem Cells Infusion	Extraction and knee infusion of Bone Marrow Autologous Stem Cells
DRUG	Acetaminophen	Acetaminophen (750mg orally TID) administration

Timeline

• Start date: 2011-08-01
• Primary completion: 2013-08-01
• Completion: 2014-05-01
• First posted: 2011-12-05
• Last updated: 2016-03-01

Locations

2 sites across 1 country: Mexico