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Comparison of BioCart™II With Microfracture for Treatment of Cartilage Defects of the Femoral Condyle

NCT00729716 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2012-04-17

No results posted yet for this study

Summary

BioCart™II is a novel scaffold seeded with autologous chondrocytes to be used to repair cartilage lesions of the knee. This study is designed to compare the efficacy and safety of BioCart™II treatment compared to microfracture which is the classical method of treatment.

Conditions

  • Symptomatic Cartilage Defects of the Femoral Condyle

Interventions

BIOLOGICAL

BioCart™II

A cartilage biopsy will be harvested from patients during arthroscopy and used for chondrocyte isolation, culture and future implantation. Subjects will also have about 80 ml venous blood drawn for autologous cell culture medium. Two-four weeks following biopsy harvest, BioCart™II will be implanted into the cartilage defect after careful debridement via miniarthrotomy.

PROCEDURE

Microfracture

MF procedure will be carried out according to accepted practice. After careful debridement multiple perforations, or microfractures, are made in the subchondral bone using an awl. The released bone marrow forms a clot at the lesion site which is an enriched environment for new tissue formation. With the subject's consent a cartilage biopsy will be taken (at least 150 mg) and about 80 ml venous blood withdrawn. This will be used for chondrocyte culture and cryopreservation in case a later BioCart™II implantation is required after failure of the microfracture procedure.

Sponsors & Collaborators

  • ProChon Biotech Ltd

    lead INDUSTRY

Principal Investigators

  • Avner Yayon, PhD MD · ProChon Biotech Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2012-05-31
Completion
2015-05-31

Countries

  • United States
  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00729716 on ClinicalTrials.gov