Autologous Stem Cells in Osteoarthritis

Study Overview
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Brief Summary
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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.

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

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Procedure: Bone Marrow Autologous Stem Cells Infusion
* Drug: Acetaminophen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Patients treated with Acetaminophen | Drug: Acetaminophen<br>* Acetaminophen (750mg orally TID) administration<br>* Other names: Knee treatment with NSAIDs;|
| Experimental: Experimental<br>Patients who underwent a BMASC extraction and joint infusion | Procedure: Bone Marrow Autologous Stem Cells Infusion<br>* Extraction and knee infusion of Bone Marrow Autologous Stem Cells<br>* Other names: Knee treatment with stem cells;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoarthritis, knee, stem cell therapy, bone marrow, G-CSF