Intra-Articular Autologous Bone Marrow Mesenchymal Stem Cells Transplantation to Treat Mild to Moderate Osteoarthritis

Phase 2

• Conditions: Osteoarthritis
• Interventions: Drug: Hyaluronic Acid; Biological: Autologous bone marrow-derived mesenchymal stem cells

• Registration Number: NCT01459640
• Lead Sponsor: National University of Malaysia

Brief Summary

Osteoarthritis is a progressively degenerative disease resulting in increasing pain, impairment and ultimately disability. While the available treatments seek to ameliorate pain or improve mobility, these treatments rarely modify the course of the disease, but rather attend to its consequences. For early stage osteoarthritis, treatment is largely limited to addressing the symptoms of inflammation with non-steroidal anti-inflammatory drugs (NSAIDs). These drugs do not stop the progression of the condition or regenerates damaged cartilage.

This is a randomized and open labelled study aimed to determine the efficacy of intra-articular implantation of autologous bone marrow-derived mesenchymal stem cells in patients with mild to moderate osteoarthritis.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Status Verified: 2011-10
• Study First Submitted: 2011-10-24
• Study First Submitted QC: 2011-10-24
• Last Update Submitted: 2011-10-24
• Study First Posted: 2011-10-25
• Last Update Posted: 2011-10-25
• Primary Completion: 2014-03
• Study Completion: 2014-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Diagnosed with mild to moderate osteoarthritis based on Kellgren-Lawrence radiographic classification
• Has a history of joint swelling, pain, stiffness, altered gait and loss of motion due to degenerative cartilage

Exclusion Criteria

• Has systemic bone or cartilage disorders
• Has significant vascular impairment proximal to implant site
• Has substantial joint destabilization including extensive osteophyte formation
• Has substantial surface erosion of the weight-bearing articular cartilage
• Evidence of infection or fractures in or around the joint
• Contraindication to bone marrow aspiration
• Any acute or chronic communicable diseases including Hepatitis B, Hepatitis C and HIV
• Any past history of neoplasia and primary hematological disease
• Renal impairment indicated by serum creatinine greater than 200mM
• Liver impairment indicated by serum aspartate transaminase and serum alanine transaminase greater than 120 IU
• Any other co-morbidity which the physician deems as a contraindication to stem cell transplantation and bone marrow biopsy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hyaluronic acid	Hyaluronic Acid	-
Bone marrow mesenchymal stem cells	Autologous bone marrow-derived mesenchymal stem cells	Autologous bone marrow-derived mesenchymal stem cells

Primary Outcome Measures

Name	Time	Method
Change from baseline in cartilage thickness at 12 months by MRI	12 months

Secondary Outcome Measures

Name	Time	Method
IKDC Subjective Knee Evaluation Form (2000)	1 month, 3 months, 6 months, 9 months, 12 months
Visual Analog Score	1 month, 3 months, 6 months, 9 months, 12 months
Change from baseline in progression of osteoarthritis at 12 months by plain radiograph (X-ray)	12 months

Trial Locations

Locations (1)

UKM Medical Centre; 🇲🇾 Kuala Lumpur, Malaysia