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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2011 by National University of Malaysia.
Recruitment status was:  Recruiting
Cytopeutics Pte. Ltd.
Information provided by (Responsible Party):
Dr Ya Mohammad Hassan Shukur, National University of Malaysia Identifier:
First received: October 24, 2011
Last updated: NA
Last verified: October 2011
History: No changes posted

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.

Condition Intervention Phase
Drug: Hyaluronic Acid
Biological: Autologous bone marrow-derived mesenchymal stem cells
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Phase 2 Study Assessing the Efficacy of Intra-Articular Autologous Mesenchymal Stem Cells in Patients With Mild to Moderate Osteoarthritis

Resource links provided by NLM:

Further study details as provided by National University of Malaysia:

Primary Outcome Measures:
  • Change from baseline in cartilage thickness at 12 months by MRI [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Visual Analog Score [ Time Frame: 1 month, 3 months, 6 months, 9 months, 12 months ]
  • IKDC Subjective Knee Evaluation Form (2000) [ Time Frame: 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) [ Time Frame: 12 months ]

Estimated Enrollment: 50
Study Start Date: March 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Hyaluronic acid Drug: Hyaluronic Acid
Intra-articular injection; 30mg/2ml; three-weekly injection regimen
Other Name: Orthovisc
Experimental: Bone marrow mesenchymal stem cells
Autologous bone marrow-derived mesenchymal stem cells
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)


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01459640

UKM Medical Centre
Kuala Lumpur, Malaysia, 56000
Sponsors and Collaborators
National University of Malaysia
Cytopeutics Pte. Ltd.
Principal Investigator: Ya Mohammad Hassan Shukur, MD UKM Medical Centre
  More Information

Responsible Party: Dr Ya Mohammad Hassan Shukur, Senior Consultant Orthopedic Surgeon, National University of Malaysia Identifier: NCT01459640     History of Changes
Other Study ID Numbers: FF-114-2011 
Study First Received: October 24, 2011
Last Updated: October 24, 2011

Keywords provided by National University of Malaysia:
Bone marrow
Mesenchymal stem cells
Mild osteoarthritis
Moderate osteoarthritis

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Protective Agents processed this record on January 19, 2017