MedTrace Logo

Neocartilage Implant to Treat Cartilage Lesions of the Knee

NCT01400607 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2017-08-31

No results posted yet for this study

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.

Conditions

  • Articular Cartilage Disorder
  • Degeneration; Articular Cartilage
  • Chronic Cartilage Injury
  • Acute Cartilage Injury
  • Defect of Articular Cartilage

Interventions

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

Sponsors & Collaborators

  • ISTO Technologies, Inc.

    lead INDUSTRY

Principal Investigators

  • Michaela Purcell · ISTO Technologies, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2020-09-30
Completion
2020-09-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01400607 on ClinicalTrials.gov