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

NCT00989794 | Unknown Phase 1 DMC

• 1 other identifier: CLN 004-00
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Cartilage Lesion to the Femoral Condyle

Keywords

cartilage; implantation; chondrocyte; condyle

Outcome Measures

Primary Outcomes (2)

• No device related AE, or SAE

  1 year

• Improvement in KOOS over baseline

  18 months

Secondary Outcomes (2)

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

  2 years

• improvement in outcome based on MRI (MOCART)

  2 years

Study Arms (1)

GelrinC

EXPERIMENTAL

GelrinC one step implantation to the femoral condyle lesion

Device: GelrinC

Interventions

GelrinC DEVICE

Applied once during surgery

GelrinC

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Regentis Biomaterials: lead

Related Publications (1)

• 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.

  PMID: 32493044 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2009
• First Posted: October 6, 2009
• Study Start: September 1, 2009
• Primary Completion: December 1, 2015
• Study Completion: March 1, 2019
• Last Updated: October 9, 2017

Record last verified: 2017-10