Autologous Stem Cells in Osteoarthritis

Phase 1

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Procedure: Bone Marrow Autologous Stem Cells Infusion; Drug: Acetaminophen

• Registration Number: NCT01485198
• Lead Sponsor: Hospital Universitario Dr. Jose E. Gonzalez

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-11-26
• Study First Submitted QC: 2011-12-02
• Study First Posted: 2011-12-05
• Primary Completion: 2013-08
• Study Completion: 2014-05
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-29
• Last Update Posted: 2016-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Bone Marrow Autologous Stem Cells Infusion	Patients who underwent a BMASC extraction and joint infusion
Control	Acetaminophen	Patients treated with Acetaminophen

Primary Outcome Measures

Name	Time	Method
Define safety of BM extraction and stem cell joint infusion.	1 week	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.

Secondary Outcome Measures

Name	Time	Method
Efficacy of BMSC joint infusion at 4 weeks	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.
Efficacy and final outcome of BMSC joint infusion at 6 months.	24 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 4 week, first week and baseline questionnaires.

Trial Locations

Locations (2)

Traumatology Service; 🇲🇽 Monterrey, Nuevo Leon, Mexico

Hematology Service; 🇲🇽 Monerrey, Nuevo Leon, Mexico