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

October 24, 2011 updated by: Dr Ya Mohammad Hassan Shukur, National University of Malaysia

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
      • Kuala Lumpur, Malaysia, 56000
        • Recruiting
        • UKM Medical Centre
        • Contact:
          • Ya Mohammad Hassan Shukur, MD
        • Principal Investigator:
          • Ya Mohammad Hassan Shukur, MD
        • Sub-Investigator:
          • Johan Ahmad, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Hyaluronic acid
Drug: Hyaluronic Acid
Intra-articular injection; 30mg/2ml; three-weekly injection regimen
Other Names:
  • 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in cartilage thickness at 12 months by MRI
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in progression of osteoarthritis at 12 months by plain radiograph (X-ray)
Time Frame: 12 months
12 months
Visual Analog Score
Time Frame: 1 month, 3 months, 6 months, 9 months, 12 months
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
1 month, 3 months, 6 months, 9 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University of Malaysia

Collaborators

Cytopeutics Pte. Ltd.

Investigators

  • Principal Investigator: Ya Mohammad Hassan Shukur, MD, UKM Medical Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Anticipated)

March 1, 2014

Study Completion (Anticipated)

March 1, 2014

Study Registration Dates

First Submitted

October 24, 2011

First Submitted That Met QC Criteria

October 24, 2011

First Posted (Estimate)

October 25, 2011

Study Record Updates

Last Update Posted (Estimate)

October 25, 2011

Last Update Submitted That Met QC Criteria

October 24, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FF-114-2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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