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Cartilage Lesion to the Femoral CondylePhase 1/2NCT00989794

Study to Evaluate the Safety and Performance of Treatment of Articular Cartilage Lesions Located on the Femoral Condyle With gelrinC

A Phase 1/2 study testing GelrinC in people with Cartilage Lesion to the Femoral Condyle, run by Regentis Biomaterials.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a single arm, open label multi-center study to determine safety and the performance of the treatment of cartilage lesions located on the femoral condyle with GelrinC. Patients meeting inclusion/exclusion criteria at screening will be enrolled into the study, and will receive treatment implantation into their… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Cartilage Lesion to the Femoral Condyle
What is being tested?
GelrinC
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
No sites listed yet
Study dates
Sep 2009to Mar 2019
Phase
Phase 1/2
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males or females 18 and 65 years of age.
  • Not more than two treatable symptomatic lesions which are NOT posterior; patient must present with pain in the index knee of moderate or severe level (VAS score ≥5)
  • If Female: Actively practicing a contraception method, or Practicing abstinence, or Surgically sterilized, or Postmenopausal
  • Understands and voluntarily signs and dates an informed consent document.
  • Grade 3 or 4 acute (traumatic) or chronic (degenerative) lesion
  • Willingness to follow standardized rehabilitation procedures.
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  • Willingness and ability to comply with the requirements of this protocol, including returning for evaluation (clinical and imaging) at periodic intervals post-treatment.
  • Study knee has intact ligaments
  • Ipsilateral knee compartment has intact menisci (or requires partial meniscectomy resulting in stable menisci)
  • Contralateral knee is asymptomatic, stable and fully functional.
  • MRI obtained preoperatively within 3 months of Surgery
  • Intraoperative Arthroscopic Confirmation:
  • one or two symptomatic lesions of the femur rated as ICRS III, or IVA with less than 6 mm of bone loss below the subchondral plate
  • Individual defect size between 1 cm2 - 6 cm2 after arthroscopic debridement

Who cannot join

  • More than two symptomatic lesions
  • Untreatable Posterior lesions
  • Lesion greater than 6cm2
  • ICRS Grade larger than grade II on a surface that directly opposes the defect
  • Osteoarthritis or avascular necrosis (clinical and/or radiographic diagnosis)
  • History of autoimmune disease or inflammatory arthropathy, such as rheumatoid arthritis, systemic lupus, active gout, septic or reactive arthritis including any history of a positive ANA blood test.
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  • History of chronic debilitating systemic disease and any other unstable cardiac and pulmonary disorders.
  • History of current or prior malignancy within the last 5 years.
  • Patients treated in the affected knee with microfracture in the last 12m months or had prior tendon repair, meniscus repair, ligament repair or realignment surgery in the last 6 months.
  • Patient with prior total or subtotal meniscectomy.
  • Body Mass Index (BMI) >32 Kg/m2
  • 'Patients with known HIV, Hepatitis A, B, or C infections or other immunodeficient state.
  • Patients requiring immunosuppressive medications.
  • Clinically significant organic disease including clinically significant cardiovascular, pulmonary, neurologic, hepatic or renal disease or other medical condition, serious concurrent illness or extenuating circumstance that, in the opinion of the investigator, make the subject a poor candidate for participation in the study.
  • Patients received any other investigational products within 6 months prior to study enrollment.
  • 17.Taking specific OA drugs such as chondroitin sulfate, diacerein, n-glucosamine, piascledine, capsaicin within 2 weeks of the screening 18.Is receiving prescription pain medication other than NSAIDs or acetaminophen for conditions unrelated to the index knee condition, chronic use of anticoagulant, or taking corticosteroids 19.Uncontrolled diabetes 20.Any concomitant painful or disabling disease of the spine, hips or lower limbs that would interfere with evaluation of the afflicted knee 21.Any clinically significant or symptomatic vascular or neurologic disorder of the lower extremities 22.Any evidence of the following diseases in the target joint : septic arthritis, inflammatory joint disease, gout, recurrent episodes of pseudogout, Paget's disease of bone, ochronosis, acromegaly, hemochromatosis, Wilson's disease, primary osteochondromatosis, heritable disorders, collagen gene mutation 23.Current diagnosis of osteomyelitis 24.Liver enzymes (SGOT, SGPT, Alkaline Phosphatase) of more than two times the upper limit of normal or any other result that is clinically important according to the Investigator 25.CRP > 10 mg/l 26.Clinically significant abnormal finding on screening laboratory parameters. 27.Clinically relevant compartment malalignment (> 5 degrees) as measured from the mechanical axis verified by clinical assessment or radiographic imaging when required 28.Patients with a history of bleeding disorders, patients receiving anti-platelet therapy or other anticoagulant medication use within 10 days prior to the beginning of the study, or patients in whom antiplatelet or other anticoagulant medication use is anticipated during the course of the study. However, patients on low-dose aspirin may be included in the study if aspirin therapy is interrupted at least 10 days before the treatment and not resumed until at least 2 weeks after the treatment.

About this study

Official title: Phase I/II Study for the Safety and Performance of GELRIN C

This is a single arm, open label multi-center study to determine safety and the performance of the treatment of cartilage lesions located on the femoral condyle with GelrinC.

Patients meeting inclusion/exclusion criteria at screening will be enrolled into the study, and will receive treatment implantation into their cartilage lesions.

Treatment will consist of GelrinC implantations at the symptomatic lesion of femur rated as ICRS III, or IVA with less than 6 mm of bone loss below the subchondral plate.

The patients will undergo a rehabilitation program during the follow up period.

Being tested
GelrinC
Keywords
cartilage, implantation, chondrocyte, condyle

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GelrinCDevice

    Applied once during surgery

Study groups in NCT00989794
Study groupRoleWhat they receive
GelrinCExperimentalGelrinC one step implantation to the femoral condyle lesion
Receives: Device: GelrinC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. No device related AE, or SAE

    Measured: 1 year

  2. Improvement in KOOS over baseline

    Measured: 18 months

Secondary outcomes (2)

  1. improvement in outcome based on questionnaires (KOOS, IKDC, VAS, SF-36)

    Measured: 2 years

  2. improvement in outcome based on MRI (MOCART)

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionDec 2015
  4. Study completionMar 2019 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00989794
Sponsor's protocol ID
CLN 004-00
Status last verified
Oct 2017
First submitted
4 Oct 2009
Last updated
9 Oct 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Schreiner MM, Raudner M, Szomolanyi P, Ohel K, Ben-Zur L, Juras V, Mlynarik V, Windhager R, Trattnig S. Chondral and Osteochondral Femoral Cartilage Lesions Treated with GelrinC: Significant Improvement of Radiological Outcome Over Time and Zonal Variation of the Repair Tissue Based on T2 Mapping at 24 Months. Cartilage. 2021 Dec;13(1_suppl):604S-616S. doi: 10.1177/1947603520926702. Epub 2020 Jun 4.

    PubMed 32493044

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing GelrinC in people with Cartilage Lesion to the Femoral Condyle, run by Regentis Biomaterials.

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 14 inclusion and 16 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 9 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

No device related AE, or SAE (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT00989794, which also lists 1 linked publication.

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 9 Oct 2017.

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