Peripheral Blood-drived Stem Cell Trial on Damaged Knee Cartilage (PBSC)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Kuala Lumpur Sports Medicine Centre.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Kuala Lumpur Sports Medicine Centre
ClinicalTrials.gov Identifier:
NCT01076673
First received: February 24, 2010
Last updated: July 15, 2011
Last verified: May 2010
  Purpose

The purpose of this study is to determine if intra-articular injections of PBSCs together with hyaluronic acid can improve the long term functional outcome of microfracture surgery in the knee joint.


Condition Intervention
Damaged Articular Cartilage
Genetic: Peripheral Blood derived Stem Cell and Hyaluronic Acid
Genetic: Hyaluronic Acid

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study on the Effects of Autologous Peripheral Blood-derived Stem Cell (PBSC) and Hyaluronic Acid Adjuvant Therapy on the Functional Outcome of Microfracture Surgery on Damaged Knee Cartilage

Resource links provided by NLM:


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

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

Secondary Outcome Measures:
  • Change in morphology after microfracture surgery using MRI scanning and to verify this histologically with cartilage biopsies taken during second look arthroscopy [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: November 2009
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PBSC and Hyaluronic Acid Genetic: Peripheral Blood derived Stem Cell and Hyaluronic Acid
Peripheral blood-derived stem cells and hyaluronic acid injections
Other Name: PBSC
Active Comparator: Hyaluronic Acid Genetic: Hyaluronic Acid
Hyaluronic acid injections

  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
  More Information

No publications provided

Responsible Party: Dr. Saw Khay Yong, 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: July 15, 2011
Health Authority: Malaysia: Medical Research Ethics Committee, University Putra Malaysia

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

ClinicalTrials.gov processed this record on September 18, 2014