Symptomatic Cartilage Defects of the Femoral CondylePhase 2NCT00729716
Comparison of BioCart™II With Microfracture for Treatment of Cartilage Defects of the Femoral Condyle
A Phase 2 study testing BioCart™II and Microfracture in people with Symptomatic Cartilage Defects of the Femoral Condyle, run by ProChon Biotech Ltd at 8 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Symptomatic Cartilage Defects of the Femoral Condyle
- What is being tested?
- BioCart™II and Microfracture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 8 sitesin 2 countries
- Study dates
- May 2008to May 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Show all 31Show fewer
- 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
- Uncontrolled diabetes
- Active joint infection
- Other unstable cardiac and pulmonary disorder
- Liver enzymes (SGOT, SGPT, alkaline phosphatase) of more then two times the upper limit of normal or any other results that in the clinical investigator's mind is important clinically
- Clinical and/or radiographic disease in the indexed affected joint that includes:
- Osteoarthritis or avascular necrosis
- Rheumatoid arthritis or a history of septic or reactive arthritis
- Gout or a history of gout or pseudogout in the affected knee
- Osteochondritis dissecans of the knee with significant bone loss
- Bipolar articular cartilage involvement (or kissing lesions) of the ipsilateral compartment (i.e >than ICRS grade 2 on the opposing articular surface)
- Associated damage to the underlying subchondral bone requiring an osteochondral graft
- History of secondary arthropathies (i.e. sickle cell disease, Hemochromatosis, or autoimmune disease)
- Receiving prescription pain medication other than NSAIDs or acetaminophen for conditions unrelated to the index knee conditions
- BMI >40 kg/m2
- Unable to undergo MRI
- Any reasons making the patient a poor candidate in the eyes of the investigator
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States5 sites
University Orthopedics Center
Altoona, Pennsylvania, 16602
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Mount Sinai Medical Center
New York, New York, 10029-6754
Southeastern Orthopedic Center
Savannah, Georgia, 31405
Tucson Orthopaedic Institute
Tucson, Arizona, 85712
Israel3 sites
Sheba Medical Center Tel Hashomer
Ramat Gan, 52662
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Assaf Harofeh Medical Center
Tsrifin, 70300
About this study
Official title: Phase II Study to Investigate the Efficacy and Safety of BioCart™II in the Treatment of Symptomatic Cartilage Defects of the Femoral Condyle in Comparison With Microfracture
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.
Read the detailed description
Full thickness cartilage lesions are typically incapable of self repair, are a source of pain and morbidity and lead to early onset osteoarthritis. A classical method of treatment has been microfracture where holes are drilled in the subchondral bone to allow influx of bone marrow cells which fill and repair the lesion. The resulting repair has been reported to be mixed fibrocartilage which is recognized to be less efficient and durable than hyaline cartilage, the physiological material making up the joint. In autologous chondrocyte implantation, a sample of cartilage is removed from a non-weight bearing region of the joint and the cells are grown and expanded in culture and then returned to the knee to repair the damaged cartilage. For implantation with BioCart™II, the chondrocytes are grown in the presence of proprietary growth factors which maintain the chondrocytes in optimal condition for subsequent repair. For implantation, the cells are seeded on a completely human three dimensional spongelike scaffold which holds the cells in the correct topology to allow for a rapid repair of the damaged joint with true physiological cartilage. BioCart™II is user friendly for the surgeon and patient alike giving it an advantage over other methods for autologous chondrocyte implantation that are in clinical use.
- Being tested
- BioCart™II, Microfracture
- Keywords
- Microfracture, Cartilage repair, Autologous chondrocyte implantation
- Medical subject headings
- Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioCart™IIBiological
Also called Autologous chondrocyte implantation, ACI
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.
MicrofractureProcedure or surgery
Also called MF
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.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | BioCart™II treatment Receives: Biological: BioCart™II |
| B | Active comparator | Microfracture procedure Receives: Procedure: Microfracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in the Lysholm joint function score of subjects in the BioCart™II study group compared with the MF study group
Measured: 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:
Measured: 12 months with optional follow up to 5 years
IKDC knee score
Measured: 12 months with optional follow up to 5 years
KOOS questionnaire
Measured: 12 months with optional follow up to 5 years
ICRS functional status
Measured: 12 months with optional follow up to 5 years
VAS pain score
Measured: 12 months with optional follow up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2008 (estimated)
- Study startMay 2008
- Primary completionMay 2012 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Symptomatic Cartilage Defects of the Femoral CondyleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ProChon Biotech Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Avner Yayon, PhD MD, Study director, ProChon Biotech Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00729716
- Sponsor's protocol ID
- BioCart™II 005-06
- Status last verified
- Mar 2012
- First submitted
- 4 Aug 2008
- Last updated
- 17 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18528742Domayer 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.
PubMed 19157740
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study to Investigate the Efficacy and Safety of BioCart™II in the Treatment of Symptomatic Cartilage Defects of the Femoral Condyle in Comparison With Microfracture
- ClinicalTrials.gov ID
- NCT00729716
- Acronym / sponsor ID
- BioCart™II 005-06
- Keywords
- Microfracture, Cartilage repair, Autologous chondrocyte implantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- ProChon Biotech LtdIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- May 2012 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 7 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Full thickness cartilage lesions are typically incapable of self repair, are a source of pain and morbidity and lead to early onset osteoarthritis. A classical method of treatment has been microfracture where holes are drilled in the subchondral bone to allow influx of bone marrow cells which fill and repair the lesion. The resulting repair has been reported to be mixed fibrocartilage which is recognized to be less efficient and durable than hyaline cartilage, the physiological material making up the joint. In autologous chondrocyte implantation, a sample of cartilage is removed from a non-weight bearing region of the joint and the cells are grown and expanded in culture and then returned to the knee to repair the damaged cartilage. For implantation with BioCart™II, the chondrocytes are grown in the presence of proprietary growth factors which maintain the chondrocytes in optimal condition for subsequent repair. For implantation, the cells are seeded on a completely human three dimensional spongelike scaffold which holds the cells in the correct topology to allow for a rapid repair of the damaged joint with true physiological cartilage. BioCart™II is user friendly for the surgeon and patient alike giving it an advantage over other methods for autologous chondrocyte implantation that are in clinical use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Biological: BioCart™IIBioCart™II treatment |
| B | Active comparator | Procedure: MicrofractureMicrofracture procedure |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (31 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioCart™IIAlso: Autologous chondrocyte implantation, ACIA 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. | Biological | A |
| MicrofractureAlso: MFMF 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. | Procedure or surgery | B |
Primary outcome
Improvement in the Lysholm joint function score of subjects in the BioCart™II study group compared with the MF study group
Time frame: 12 months with optional follow up to 5 years
5 secondary outcomes
Improvement in clinical function post implantation/surgery compared to baseline in the study group and compared with the control group, of the following:
Time frame: 12 months with optional follow up to 5 years
IKDC knee score
Time frame: 12 months with optional follow up to 5 years
KOOS questionnaire
Time frame: 12 months with optional follow up to 5 years
ICRS functional status
Time frame: 12 months with optional follow up to 5 years
VAS pain score
Time frame: 12 months with optional follow up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2012.
- Background: PubMed 18528742Nehrer 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.
- Background: PubMed 19157740Domayer 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Avner Yayon, PhD MD study director
ProChon Biotech Ltd
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BioCart™II and Microfracture in people with Symptomatic Cartilage Defects of the Femoral Condyle, run by ProChon Biotech Ltd at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in the Lysholm joint function score of subjects in the BioCart™II study group compared with the MF study group (time frame: 12 months with optional follow up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00729716, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2012.