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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
61
Extraction and knee infusion of Bone Marrow Autologous Stem Cells
Acetaminophen (750mg orally TID) administration
Hematology Service
Monerrey, Nuevo León, Mexico
Traumatology Service
Monterrey, Nuevo León, Mexico
Define safety of BM extraction and stem cell joint infusion.
Measure possible complications of procedure (e.g. pain, bleeding, infection) and range of motion through clinical examination. Apply a questionnaire consisting of validated Womac® Scale, KSS® (Knee Society Rating System), SF-36® (Health Survey Update), and VAS (Visual Analog Scale) to correlate changes at first week to the baseline questionnaire.
Time frame: 1 week
Efficacy of BMSC joint infusion at 4 weeks
Measure possible complications of procedure (e.g. pain, bleeding, infection) and range of motion through clinical examination. Apply a questionnaire consisting of validated Womac® Scale, KSS® (Knee Society Rating System), SF-36® (Health Survey Update), and VAS (Visual Analog Scale) to correlate changes with first week and baseline questionnaires.
Time frame: 4 weeks
Efficacy and final outcome of BMSC joint infusion at 6 months.
Measure possible complications of procedure (e.g. pain, bleeding, infection) and range of motion through clinical examination. Apply a questionnaire consisting of validated Womac® Scale, KSS® (Knee Society Rating System), SF-36® (Health Survey Update), and VAS (Visual Analog Scale) to correlate changes with 4 week, first week and baseline questionnaires.
Time frame: 24 weeks
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