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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2012-05-31

Brief Summary

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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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Detailed Description

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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)

Conditions

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Articular Cartilage Disorder of Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PBSC and Hyaluronic Acid

Peripheral blood stem cells and hyaluronic acid injections

Group Type EXPERIMENTAL

Peripheral blood stem cells and hyaluronic acid injections

Intervention Type BIOLOGICAL

Peripheral blood stem cells and hyaluronic acid injections

Hyaluronic Acid

Group Type ACTIVE_COMPARATOR

Hyaluronic Acid

Intervention Type DRUG

Hyaluronic acid injections

Interventions

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Peripheral blood stem cells and hyaluronic acid injections

Intervention Type BIOLOGICAL

Hyaluronic Acid

Hyaluronic acid injections

Intervention Type DRUG

Other Intervention Names

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PBSC and HA HA

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No