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OpenTrials
Completed

NCT Number: NCT01076673

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

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)

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kuala Lumpur Sports Medicine Centre

Kuala Lumpur, Malaysia

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peripheral blood stem cells and hyaluronic acid injections

Biological

Peripheral blood stem cells and hyaluronic acid injections

Other names: PBSC and HA

Hyaluronic acid

Drug

Hyaluronic acid injections

Other names: HA

Primary outcomes

  1. Change in tissue histology after subchondral drilling surgery using serial MRI scanning and cartilage biopsies

    Time frame: 18 months

Secondary outcomes

  1. Improved long term functional outcome of subchondral drilling surgery in the knee joint

    Time frame: 18 months

Sponsors and collaborators

Lead sponsor

Kuala Lumpur Sports Medicine Centre

Other

Collaborators

  • Ministry of Science, Technology and Innovation (MOSTI) Malaysia

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Feb 26, 2010
Registry last updated
Mar 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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