Autologous Stem Cells in Osteoarthritis

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Universitario Dr. Jose E. Gonzalez
• Treatments: Acetaminophen

Criteria

Inclusion Criteria:

• Patients with knee osteoarthritis grade II or III of the Kellgren-Lawrence radiographic scale

• Age > 30 years

Exclusion Criteria:

• Neurodegenerative, autoimmune, genetic or psychiatric diseases

• Active infection

• Recent joint infection

• Knee surgery history

• Knee joint fracture history