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

Osteoarthritis Clinical Trial

Official title:

Phase 2 Study Assessing the Efficacy of Intra-Articular Autologous Mesenchymal Stem Cells in Patients With Mild to Moderate Osteoarthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01459640
• Other study ID #: FF-114-2011
• Status: Recruiting
• Phase: Phase 2
• First received: October 24, 2011
• Last updated: October 24, 2011
• Start date: March 2011
• Est. completion date: March 2014

Study information

• Verified date: October 2011
• Source: National University of Malaysia
• Contact: Ya Mohammad Hassan Shukur, MD
• Email: mhassan[@]ppukm.ukm.my
• Is FDA regulated: No
• Health authority: Malaysia: Institutional Review BoardMalaysia: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Drug:
• Hyaluronic Acid
Intra-articular injection; 30mg/2ml; three-weekly injection regimen

Biological:
• Autologous bone marrow-derived mesenchymal stem cells
Single intra-articular implantation of autologous bone marrow-derived mesenchymal stem cells in hyaluronic acid "Orthovisc" (3rd injection in a three-weekly injection regimen)

Locations

Country	Name	City	State
Malaysia	UKM Medical Centre	Kuala Lumpur

Sponsors (2)

Lead Sponsor	Collaborator
National University of Malaysia	Cytopeutics Pte. Ltd.

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in cartilage thickness at 12 months by MRI		12 months	No
Secondary	Visual Analog Score		1 month, 3 months, 6 months, 9 months, 12 months	Yes
Secondary	IKDC Subjective Knee Evaluation Form (2000)		1 month, 3 months, 6 months, 9 months, 12 months	Yes
Secondary	Change from baseline in progression of osteoarthritis at 12 months by plain radiograph (X-ray)		12 months	No