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

This study has been completed.
Sponsor:
Collaborator:
Ministry of Science, Technology and Innovation (MOSTI) Malaysia
Information provided by (Responsible Party):
Dr. Khay-Yong Saw, Kuala Lumpur Sports Medicine Centre
ClinicalTrials.gov Identifier:
NCT01076673
First received: February 24, 2010
Last updated: March 12, 2015
Last verified: March 2015
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Articular Cartilage Regeneration With Autologous Peripheral Blood Stem Cells Versus Hyaluronic Acid: A Randomized, Controlled Trial

Resource links provided by NLM:


Further study details as provided by Kuala Lumpur Sports Medicine Centre:

Primary Outcome Measures:
  • Change in tissue histology after subchondral drilling surgery using serial MRI scanning and cartilage biopsies [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improved long term functional outcome of subchondral drilling surgery in the knee joint [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: October 2009
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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)

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01076673

Locations
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
Principal Investigator: Khay-Yong Saw, Dr. Kuala Lumpur Sports Medicine Centre
  More Information

Publications:
Responsible Party: Dr. Khay-Yong Saw, Consultant Orthopaedic Surgeon, Kuala Lumpur Sports Medicine Centre
ClinicalTrials.gov Identifier: NCT01076673     History of Changes
Other Study ID Numbers: KLSMC-001
Study First Received: February 24, 2010
Last Updated: March 12, 2015
Health Authority: Malaysia: Institutional Review Board

Additional relevant MeSH terms:
Cartilage Diseases
Connective Tissue Diseases
Musculoskeletal Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Viscosupplements

ClinicalTrials.gov processed this record on June 30, 2015