NCT00729716

Brief 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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2008

Longer than P75 for phase_2

Geographic Reach
2 countries

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 7, 2008

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

April 17, 2012

Status Verified

March 1, 2012

Enrollment Period

4 years

First QC Date

August 4, 2008

Last Update Submit

April 16, 2012

Conditions

Symptomatic Cartilage Defects of the Femoral Condyle

Keywords

MicrofractureCartilage repairAutologous chondrocyte implantation

Outcome Measures

Primary Outcomes (1)

  • Improvement in the Lysholm joint function score of subjects in the BioCart™II study group compared with the MF study group

    12 months with optional follow up to 5 years

Secondary Outcomes (5)

  • Improvement in clinical function post implantation/surgery compared to baseline in the study group and compared with the control group, of the following:

    12 months with optional follow up to 5 years

  • IKDC knee score

    12 months with optional follow up to 5 years

  • KOOS questionnaire

    12 months with optional follow up to 5 years

  • ICRS functional status

    12 months with optional follow up to 5 years

  • VAS pain score

    12 months with optional follow up to 5 years

Study Arms (2)

A

EXPERIMENTAL

BioCart™II treatment

Biological: BioCart™II

B

ACTIVE COMPARATOR

Microfracture procedure

Procedure: Microfracture

Interventions

BioCart™IIBIOLOGICAL

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.

Also known as: Autologous chondrocyte implantation, ACI
A
MicrofracturePROCEDURE

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.

Also known as: MF
B

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 16 to 60 years
  • Femoral condyle lesion (medial, lateral or trochlea)
  • Single contained lesion
  • Symptomatic (moderate to severe pain on VAS)
  • Caused by trauma or OCD
  • Depth of lesion up to 6 mm
  • Size of lesion 1.5-7.5 cm2
  • No general bone or cartilage pathology
  • No limb mal-alignment (long leg standing X-ray)
  • Mechanically stable knee
  • Accompanying pathology menisectomy up to 50%
  • Willing and able to comply with protocol and undergo vigorous rehabilitation
  • Signed informed consent

You may not qualify if:

  • Multiple cartilage lesions of the knee, other location than femoral condyle (medial, lateral or trochlear), deeper than 6 mm, smaller than 1.5cm2 or greater than 7.5cm2, mild symptoms, caused by reason other than trauma or OCD, unstable knee, accompanying pathology other than 50% menisectomy.
  • Hyaluronic acid knee injections in the past 3 months,
  • History of chronic bone or cartilage disorder, bilateral knee pain and/or cartilage lesion
  • History of any neoplastic disease, or chemotherapy treatment
  • Chronic steroid intake, chronic pain medication use for conditions other than the involved knee, use of blood thinners (during the past 10 days prior to enrollment)
  • History of allergy or atopic disease, sensitivity to blood products
  • Evidence of any significant systemic disease, known coagulopathies or acute injury that might compromise the patient's welfare
  • Pregnant or lactating women
  • Substance or alcohol abuse
  • Microfracture to the affected knee within the previous 2 years
  • Participation in concurrent trials
  • Participation in previous trials within 3 months
  • Malignancy
  • Taking specific drugs for osteoarthritis, such as chondroitin sulfate, diacerein, n-glucosamine, piaseledine, or capsaicin within 2 weeks of the baseline visit
  • Chronic use of anticoagulants
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Tucson Orthopaedic Institute

Tucson, Arizona, 85712, United States

Location

Southeastern Orthopedic Center

Savannah, Georgia, 31405, United States

Location

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

Location

Mount Sinai Medical Center

New York, New York, 10029-6754, United States

Location

University Orthopedics Center

Altoona, Pennsylvania, 16602, United States

Location

Sheba Medical Center Tel Hashomer

Ramat Gan, 52662, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Assaf Harofeh Medical Center

Ẕerifin, 70300, Israel

Location

Related Publications (2)

  • Nehrer S, Chiari C, Domayer S, Barkay H, Yayon A. Results of chondrocyte implantation with a fibrin-hyaluronan matrix: a preliminary study. Clin Orthop Relat Res. 2008 Aug;466(8):1849-55. doi: 10.1007/s11999-008-0322-4. Epub 2008 Jun 5.

    PMID: 18528742BACKGROUND

  • Domayer SE, Welsch GH, Nehrer S, Chiari C, Dorotka R, Szomolanyi P, Mamisch TC, Yayon A, Trattnig S. T2 mapping and dGEMRIC after autologous chondrocyte implantation with a fibrin-based scaffold in the knee: preliminary results. Eur J Radiol. 2010 Mar;73(3):636-42. doi: 10.1016/j.ejrad.2008.12.006. Epub 2009 Jan 20.

    PMID: 19157740BACKGROUND

MeSH Terms

Conditions

Fractures, Stress

Interventions

Arthroplasty, Subchondral

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and Injuries

Intervention Hierarchy (Ancestors)

ArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery Procedures

Study Officials

  • Avner Yayon, PhD MD

    ProChon Biotech Ltd

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2008

First Posted

August 7, 2008

Study Start

May 1, 2008

Primary Completion

May 1, 2012

Study Completion

May 1, 2015

Last Updated

April 17, 2012

Record last verified: 2012-03

Locations

US(5)IL(3)