Autologous Stem Cells in Osteoarthritis

Hospital Universitario Dr. Jose E. Gonzalez

Status and phase: Completed; Phase 1

Conditions: Osteoarthritis, Knee

Treatments: Drug: Acetaminophen; Procedure: Bone Marrow Autologous Stem Cells Infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT01485198

HE11-022

Details and patient eligibility

About

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.

Enrollment: 61 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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61 participants in 2 patient groups

Control

Active Comparator group

Description:

Patients treated with Acetaminophen

Treatment:

Drug: Acetaminophen

Experimental

Experimental group

Description:

Patients who underwent a BMASC extraction and joint infusion

Treatment:

Procedure: Bone Marrow Autologous Stem Cells Infusion