Neocartilage Implant to Treat Cartilage Lesions of the Knee

Randomized Controlled Trial to Evaluate the Efficacy of a Neocartilage Implant in the Management of ICRS Grade 3 to 4 Articular Cartilage Lesions of the Knee

ISTO Technologies, Inc. is proposing a clinical study with 225 subjects, to establish the safety and efficacy of the Neocartilage Implant for the treatment of ICRS Grade 3 and 4 articular cartilage lesions of the knee compared to microfracture treatment.

Study Overview

• Status: Terminated
• Conditions: Defect of Articular Cartilage; Articular Cartilage Disorder; Degeneration; Articular Cartilage; Chronic Cartilage Injury; Acute Cartilage Injury
• Intervention / Treatment: Biological: Neocartilage Implant/DeNovo® ET (Engineered Tissue Graft); Other: Microfracture

Detailed Description

In the United States alone, more than 500,000 cartilage lesions per year require some treatment to reduce pain, restore joint mobility, and prevent further damage caused by the progression of osteoarthritis. The lack of effective cartilage repair approaches or products for restoration of defective articular cartilage to its native, hyaline morphology only continues to exacerbate the incidence of osteoarthritis as these initial defects enlarge and degrade over a 10 to 20 year period. The repair of cartilage, especially in the knee, remains a formidable clinical challenge. Regenerative medicine approaches to cartilage repair have only begun to be explored as possible options and there is a clear trend toward biological solutions for the repair and regeneration of damaged or diseased articular cartilage. The study was designed to compare how well the Neocartilage Implant works against the microfracture therapy, a widely used and accepted cartilage repair therapy. Data to be collected include Pain and Function in Daily Living scores, symptoms, Function in Sports and Recreation, and Knee Related Quality of Life. Additionally, MRI and X-rays will be collected to evaluate the cartilage repair progress. These assessments will be used through the five years of post-operative follow-up.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90045
      • Kerlan Jobe Orthopaedic Clinic
    • Santa Monica, California, United States, 90404
      • Santa Monica Orthopaedic & Sports Medicine Group
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
  • New York
    • New York, New York, United States, 10021
      • Hospital for Special Surgery -Sports Medicine and Shoulder Service
    • New York, New York, United States, 10065
      • Insall Scott Kelly Institute for Orthopaedics & Sports Medicine
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43221
      • The Ohio State University Sports Medicine Center
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • The Hawkins Foundation
  • Texas
    • Houston, Texas, United States, 77030
      • The Methodist Hospital Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Generally, the following inclusion criteria must be met, however, this is not a complete list.

• Male or Female between the ages of 18 and 60
• (1) or (2) articular cartilage lesions of the distal femur ranging in no more than 5 cm2 each
• Ipsilateral knee compartment has intact menisci (or meniscectomized remnant with > 5mm wide rim) and stable ligaments in the affected knee
• 3 months out from initiation of conservative non-surgical management (e.g.hyaluronic acid injection, activity modification) or previous minimal surgical intervention (e.g., arthroscopic lavage, debridement) or 12 months out from marrow stimulation for this condition

Exclusion Criteria:

Generally, if a potential participant meets any of the following criterions, they will not be eligible for this study. Additionally, more criteria will be evaluated to confirm eligibility as this list is not a complete list of criteria.

• Osteoarthritis
• Rheumatoid arthritis
• History of septic or reactive arthritis
• Gout or a history of gout or pseudo-gout in the affected knee
• Osteochondritis dissecans or osteochondral lesions of the knee with bone loss > 6mm deep
• 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
• Is pregnant or breast-feeding
• Has a BMI > 35 (kg/m2)
• Has prior total meniscectomy of either knee
• Has received, within the past three months, intra-articular hyaluronic acid therapy, or steroid therapy
• Has more than two clinically relevant chondral lesion(s) on the index knee

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Neocartilage Implant; Neocartilage Implant surgically implanted and affixed to subchondral bone using commercial fibrin during mini-open knee arthrotomy.	Biological: Neocartilage Implant/DeNovo® ET (Engineered Tissue Graft); The Neocartilage Implant is a cartilage repair technology cultured from juvenile human cartilage cells.; Other Names: RevaFlex
Other: Microfracture; Standard of care cartilage repair technique.	Other: Microfracture; Marrow stimulation using the microfracture technique; performed arthroscopically; Other Names: marrow stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Injury and Osteoarthritis Outcomes Scores (KOOS)	Knee Injury and Osteoarthritis Outcomes Scores (KOOS) Pain and Function in Daily Living (ADL) subscales.	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IKDC Knee Examination		Baseline, 6 week, 6, 12, 18, 24 months and annually through 5 years
Subject reported questionnaires	Various questionnaires are required to be completed by the subject before and after treatment throughout the study.	Baseline, 6 week, 6, 12, 18, 24 months and annually through 5 years

Collaborators and Investigators

• Sponsor: ISTO Technologies, Inc.
• Investigators: Study Director: Michaela Purcell, ISTO Technologies, Inc.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: July 20, 2011
• First Submitted That Met QC Criteria: July 21, 2011
• First Posted (Estimate): July 22, 2011

Study Record Updates

• Last Update Posted (Actual): August 31, 2017
• Last Update Submitted That Met QC Criteria: August 29, 2017
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: knee surgery; cartilage; knee pain; cartilage injury; cells; cartilage defect; cartilage damage; cartilage lesion; cartilage repair; articular cartilage lesion; juvenile; articular cartilage defect; ISTO Technologies; Neocartilage; RevaFlex
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Connective Tissue Diseases; Wounds and Injuries; Cartilage Diseases
• Other Study ID Numbers: ISTO NEO-01-09-01