Neocartilage Implant to Treat Cartilage Lesions of the Knee

Defect of Articular Cartilage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01400607
• Other study ID #: ISTO NEO-01-09-01
• Status: Terminated
• Phase: Phase 3
• First received: July 20, 2011
• Last updated: August 29, 2017
• Start date: July 2011
• Est. completion date: September 2020

Study information

• Verified date: September 2016
• Source: ISTO Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Cartilage Injury
• Articular Cartilage Disorder
• Cartilage Diseases
• Chronic Cartilage Injury
• Defect of Articular Cartilage
• Degeneration; Articular Cartilage
• Wounds and Injuries

Intervention

Biological:
• Neocartilage Implant/DeNovo® ET (Engineered Tissue Graft)
The Neocartilage Implant is a cartilage repair technology cultured from juvenile human cartilage cells.

Other:
• Microfracture
Marrow stimulation using the microfracture technique; performed arthroscopically

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	The Ohio State University Sports Medicine Center	Columbus	Ohio
United States	The Hawkins Foundation	Greenville	South Carolina
United States	The Methodist Hospital Research Institute	Houston	Texas
United States	Kerlan Jobe Orthopaedic Clinic	Los Angeles	California
United States	Hospital for Special Surgery -Sports Medicine and Shoulder Service	New York	New York
United States	Insall Scott Kelly Institute for Orthopaedics & Sports Medicine	New York	New York
United States	Santa Monica Orthopaedic & Sports Medicine Group	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
ISTO Technologies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	IKDC Knee Examination		Baseline, 6 week, 6, 12, 18, 24 months and annually through 5 years
Secondary	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