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

Phase 2

Completed

• Conditions: Articular Cartilage Disorder of Knee
• Interventions: Biological: Peripheral blood stem cells and hyaluronic acid injections; Drug: Hyaluronic Acid

• Registration Number: NCT01076673
• Lead Sponsor: Kuala Lumpur Sports Medicine Centre

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)

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-02-24
• Study First Submitted QC: 2010-02-25
• Study First Posted: 2010-02-26
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-12
• Last Update Posted: 2015-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PBSC and Hyaluronic Acid	Peripheral blood stem cells and hyaluronic acid injections	Peripheral blood stem cells and hyaluronic acid injections
Hyaluronic Acid	Hyaluronic Acid	Hyaluronic Acid

Primary Outcome Measures

Name	Time	Method
Change in tissue histology after subchondral drilling surgery using serial MRI scanning and cartilage biopsies	18 months

Secondary Outcome Measures

Name	Time	Method
Improved long term functional outcome of subchondral drilling surgery in the knee joint	18 months

Trial Locations

Locations (1)

Kuala Lumpur Sports Medicine Centre; 🇲🇾 Kuala Lumpur, Malaysia