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

National University of Malaysia

Status and phase: Unknown; Phase 2

Conditions: Osteoarthritis

Treatments: Biological: Autologous bone marrow-derived mesenchymal stem cells; Drug: Hyaluronic Acid

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01459640

FF-114-2011

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Hyaluronic acid

Active Comparator group

Treatment:

Drug: Hyaluronic Acid

Bone marrow mesenchymal stem cells

Experimental group

Description:

Autologous bone marrow-derived mesenchymal stem cells

Treatment:

Biological: Autologous bone marrow-derived mesenchymal stem cells