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Effect of Autologous Peripheral Blood Stem Cell Treatment on Articular Cartilage Regeneration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01076673
Recruitment Status : Completed
First Posted : February 26, 2010
Last Update Posted : March 17, 2015
Sponsor:
Collaborator:
Ministry of Science, Technology and Innovation (MOSTI) Malaysia
Information provided by (Responsible Party):
Dr. Khay-Yong Saw, Kuala Lumpur Sports Medicine Centre

Study Description
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Brief Summary:
The purpose of this study was to compare histologic and MRI evaluation of articular cartilage regeneration in patients with chondral lesions treated by arthroscopic subchondral drilling followed by postoperative intra-articular injections of hyaluronic acid (HA) with and without peripheral blood stem cells (PBSC)

Condition or disease Intervention/treatment Phase
Articular Cartilage Disorder of Knee Biological: Peripheral blood stem cells and hyaluronic acid injections Drug: Hyaluronic Acid Phase 2

Detailed Description:
The purpose of this study was to compare histologic and magnetic resonance imaging (MRI) evaluation of articular cartilage regeneration in patients with chondral lesions treated by arthroscopic subchondral drilling followed by postoperative intra-articular injections of hyaluronic acid (HA) with and without peripheral blood stem cells (PBSC)
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Articular Cartilage Regeneration With Autologous Peripheral Blood Stem Cells Versus Hyaluronic Acid: A Randomized, Controlled Trial
Study Start Date : October 2009
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sports Fitness

Arms and Interventions
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Arm Intervention/treatment
Experimental: PBSC and Hyaluronic Acid
Peripheral blood stem cells and hyaluronic acid injections
 Biological: Peripheral blood stem cells and hyaluronic acid injections
Peripheral blood stem cells and hyaluronic acid injections
Other Name: PBSC and HA
Active Comparator: Hyaluronic Acid
Hyaluronic Acid
 Drug: Hyaluronic Acid
Hyaluronic acid injections
Other Name: HA


Outcome Measures
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Primary Outcome Measures :
  1. Change in tissue histology after subchondral drilling surgery using serial MRI scanning and cartilage biopsies [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Improved long term functional outcome of subchondral drilling surgery in the knee joint [ Time Frame: 18 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who have signed informed consent form
  • Patients with only unilateral isolated or multiple knee articular cartilage lesions demonstrated MRI scanning, with up to one previous operation on that knee
  • Patients who are either male or female aged between 18 to 50 years old, corresponding to availability of normative International Knee Documentation Committee (IKDC) data.
  • Female patients of childbearing age must have negative pregnancy tests and are advised to take contraceptive precautions throughout the study.

Exclusion Criteria:

  • Patients with bilateral knee lesions
  • Patients with the presence of ligamentous injury which would require reconstruction, varus or valgus deformity greater than 10 degrees, previous open total menisectomy requiring osteotomy, and cases that require complex surgery prior to cartilage regeneration
  • Patients with significant cognitive impairment, non-ambulatory status or lower extremities amputation other than toes, serious illness or medication affecting operative risk or wound healing (e.g. steroid intake, anticoagulation), and poorly controlled diabetes mellitus with a baseline HbA1c more than 8
  • Patients with significant peripheral vascular disease as indicated by absent dorsalis pedis or posterior tibial pulses.
  • Patients who cannot read English will be excluded from the study as they will be unable to complete the study questionnaires in an objective manner
  • Female patients who are pregnant
  • Patients with any contradictions to MRI scanning
  • Patients with body mass index (BMI) of over 35
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01076673


Locations
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Malaysia
Kuala Lumpur Sports Medicine Centre
Kuala Lumpur, Malaysia
Sponsors and Collaborators
Kuala Lumpur Sports Medicine Centre
Ministry of Science, Technology and Innovation (MOSTI) Malaysia
Investigators
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Principal Investigator: Khay-Yong Saw, Dr. Kuala Lumpur Sports Medicine Centre
More Information
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Publications of Results:

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Responsible Party: Dr. Khay-Yong Saw, Consultant Orthopaedic Surgeon, Kuala Lumpur Sports Medicine Centre
ClinicalTrials.gov Identifier: NCT01076673    
Other Study ID Numbers: KLSMC-001
First Posted: February 26, 2010    Key Record Dates
Last Update Posted: March 17, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Cartilage Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Hyaluronic Acid
Adjuvants, Immunologic
 Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents