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

This study is currently recruiting participants.
Verified October 2011 by National University of Malaysia
Sponsor:
Collaborator:
Cytopeutics Pte. Ltd.
Information provided by (Responsible Party):
Dr Ya Mohammad Hassan Shukur, National University of Malaysia
ClinicalTrials.gov Identifier:
NCT01459640
First received: October 24, 2011
Last updated: NA
Last verified: October 2011
History: No changes posted
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visual Analog Score [ Time Frame: 1 month, 3 months, 6 months, 9 months, 12 months ] [ Designated as safety issue: Yes ]
  • IKDC Subjective Knee Evaluation Form (2000) [ Time Frame: 1 month, 3 months, 6 months, 9 months, 12 months ] [ Designated as safety issue: Yes ]
  • Change from baseline in progression of osteoarthritis at 12 months by plain radiograph (X-ray) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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)

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01459640

Contacts
Contact: Ya Mohammad Hassan Shukur, MD mhassan@ppukm.ukm.my

Locations
Malaysia
UKM Medical Centre Recruiting
Kuala Lumpur, Malaysia, 56000
Contact: Ya Mohammad Hassan Shukur, MD            
Principal Investigator: Ya Mohammad Hassan Shukur, MD            
Sub-Investigator: Johan Ahmad, MD            
Sponsors and Collaborators
National University of Malaysia
Cytopeutics Pte. Ltd.
Investigators
Principal Investigator: Ya Mohammad Hassan Shukur, MD UKM Medical Centre
  More Information

No publications provided

Responsible Party: Dr Ya Mohammad Hassan Shukur, Senior Consultant Orthopedic Surgeon, National University of Malaysia
ClinicalTrials.gov Identifier: NCT01459640     History of Changes
Other Study ID Numbers: FF-114-2011
Study First Received: October 24, 2011
Last Updated: October 24, 2011
Health Authority: Malaysia: Institutional Review Board
Malaysia: Ministry of Health

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

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
 Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013