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Trial record 13 of 54 for:    stem cell arthritis AND bone marrow

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

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ClinicalTrials.gov Identifier: NCT01459640
Recruitment Status : Unknown
Verified October 2011 by Dr Ya Mohammad Hassan Shukur, National University of Malaysia.
Recruitment status was:  Recruiting
First Posted : October 25, 2011
Last Update Posted : October 25, 2011
Sponsor:
Collaborator:
Cytopeutics Pte. Ltd.
Information provided by (Responsible Party):
Dr Ya Mohammad Hassan Shukur, National University of Malaysia

Tracking Information
First Submitted Date  ICMJE October 24, 2011
First Posted Date  ICMJE October 25, 2011
Last Update Posted Date October 25, 2011
Study Start Date  ICMJE March 2011
Estimated Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 24, 2011)
Change from baseline in cartilage thickness at 12 months by MRI [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 24, 2011)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intra-Articular Autologous Bone Marrow Mesenchymal Stem Cells Transplantation to Treat Mild to Moderate Osteoarthritis
Official Title  ICMJE Phase 2 Study Assessing the Efficacy of Intra-Articular Autologous Mesenchymal Stem Cells in Patients With Mild to Moderate Osteoarthritis
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Osteoarthritis
Intervention  ICMJE
  • Drug: Hyaluronic Acid
    Intra-articular injection; 30mg/2ml; three-weekly injection regimen
    Other Name: Orthovisc
  • 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)
Study Arms  ICMJE
  • Active Comparator: Hyaluronic acid
    Intervention: Drug: Hyaluronic Acid
  • Experimental: Bone marrow mesenchymal stem cells
    Autologous bone marrow-derived mesenchymal stem cells
    Intervention: Biological: Autologous bone marrow-derived mesenchymal stem cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 24, 2011)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2014
Estimated Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Malaysia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01459640
Other Study ID Numbers  ICMJE FF-114-2011
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Ya Mohammad Hassan Shukur, National University of Malaysia
Study Sponsor  ICMJE National University of Malaysia
Collaborators  ICMJE Cytopeutics Pte. Ltd.
Investigators  ICMJE
Principal Investigator: Ya Mohammad Hassan Shukur, MD UKM Medical Centre
PRS Account National University of Malaysia
Verification Date October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP