Effect of Autologous Peripheral Blood Stem Cell Treatment on Articular Cartilage Regeneration
Primary Purpose
Articular Cartilage Disorder of Knee
Status
Completed
Phase
Phase 2
Locations
Malaysia
Study Type
Interventional
Intervention
Peripheral blood stem cells and hyaluronic acid injections
Hyaluronic Acid
Sponsored by
About this trial
This is an interventional treatment trial for Articular Cartilage Disorder of Knee
Eligibility 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
Sites / Locations
- Kuala Lumpur Sports Medicine Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PBSC and Hyaluronic Acid
Hyaluronic Acid
Arm Description
Peripheral blood stem cells and hyaluronic acid injections
Hyaluronic Acid
Outcomes
Primary Outcome Measures
Change in tissue histology after subchondral drilling surgery using serial MRI scanning and cartilage biopsies
Secondary Outcome Measures
Improved long term functional outcome of subchondral drilling surgery in the knee joint
Full Information
NCT ID
NCT01076673
First Posted
February 24, 2010
Last Updated
March 12, 2015
Sponsor
Kuala Lumpur Sports Medicine Centre
Collaborators
Ministry of Science, Technology and Innovation (MOSTI) Malaysia
1. Study Identification
Unique Protocol Identification Number
NCT01076673
Brief Title
Effect of Autologous Peripheral Blood Stem Cell Treatment on Articular Cartilage Regeneration
Official Title
Articular Cartilage Regeneration With Autologous Peripheral Blood Stem Cells Versus Hyaluronic Acid: A Randomized, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kuala Lumpur Sports Medicine Centre
Collaborators
Ministry of Science, Technology and Innovation (MOSTI) Malaysia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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)
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Articular Cartilage Disorder of Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PBSC and Hyaluronic Acid
Arm Type
Experimental
Arm Description
Peripheral blood stem cells and hyaluronic acid injections
Arm Title
Hyaluronic Acid
Arm Type
Active Comparator
Arm Description
Hyaluronic Acid
Intervention Type
Biological
Intervention Name(s)
Peripheral blood stem cells and hyaluronic acid injections
Other Intervention Name(s)
PBSC and HA
Intervention Description
Peripheral blood stem cells and hyaluronic acid injections
Intervention Type
Drug
Intervention Name(s)
Hyaluronic Acid
Other Intervention Name(s)
HA
Intervention Description
Hyaluronic acid injections
Primary Outcome Measure Information:
Title
Change in tissue histology after subchondral drilling surgery using serial MRI scanning and cartilage biopsies
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Improved long term functional outcome of subchondral drilling surgery in the knee joint
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khay-Yong Saw, Dr.
Organizational Affiliation
Kuala Lumpur Sports Medicine Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kuala Lumpur Sports Medicine Centre
City
Kuala Lumpur
Country
Malaysia
12. IPD Sharing Statement
Citations:
PubMed Identifier
23380230
Citation
Saw KY, Anz A, Siew-Yoke Jee C, Merican S, Ching-Soong Ng R, Roohi SA, Ragavanaidu K. Articular cartilage regeneration with autologous peripheral blood stem cells versus hyaluronic acid: a randomized controlled trial. Arthroscopy. 2013 Apr;29(4):684-94. doi: 10.1016/j.arthro.2012.12.008. Epub 2013 Feb 4.
Results Reference
result
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Effect of Autologous Peripheral Blood Stem Cell Treatment on Articular Cartilage Regeneration
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