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

Articular Cartilage Disorder of Knee Clinical Trial

Official title:

Articular Cartilage Regeneration With Autologous Peripheral Blood Stem Cells Versus Hyaluronic Acid: A Randomized, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01076673
• Other study ID #: KLSMC-001
• Status: Completed
• Phase: Phase 2
• First received: February 24, 2010
• Last updated: March 12, 2015
• Start date: October 2009
• Est. completion date: May 2012

Study information

• Verified date: March 2015
• Source: Kuala Lumpur Sports Medicine Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: Institutional Review Board
• Study type: Interventional

Clinical Trial 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)

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Articular Cartilage Disorder of Knee
• Cartilage Diseases

Intervention

Biological:
• Peripheral blood stem cells and hyaluronic acid injections
Peripheral blood stem cells and hyaluronic acid injections

Drug:
• Hyaluronic Acid
Hyaluronic acid injections

Locations

Country	Name	City	State
Malaysia	Kuala Lumpur Sports Medicine Centre	Kuala Lumpur

Sponsors (2)

Lead Sponsor	Collaborator
Kuala Lumpur Sports Medicine Centre	Ministry of Science, Technology and Innovation (MOSTI) Malaysia

Country where clinical trial is conducted

Malaysia, 

References & Publications (1)

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. d — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in tissue histology after subchondral drilling surgery using serial MRI scanning and cartilage biopsies		18 months	No
Secondary	Improved long term functional outcome of subchondral drilling surgery in the knee joint		18 months	No