This trial is active, not recruiting.

Condition damaged articular cartilage
Treatments peripheral blood derived stem cell and hyaluronic acid, hyaluronic acid
Sponsor Kuala Lumpur Sports Medicine Centre
Start date November 2009
End date April 2012
Trial size 50 participants
Trial identifier NCT01076673, KLSMC-001


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
peripheral blood derived stem cell and hyaluronic acid PBSC
Peripheral blood-derived stem cells and hyaluronic acid injections
(Active Comparator)
hyaluronic acid
Hyaluronic acid injections

Primary Outcomes

Improved long term functional outcome of microfracture surgery in the knee joint
time frame: 18 months

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 50 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in July 2011.
Information provided to ClinicalTrials.gov by Kuala Lumpur Sports Medicine Centre.