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Study of TG-C in Patients With Grade 3 Degenerative Joint Disease of the Knee

NCT01221441 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2016-02-15

Study results available
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Summary

The purpose of this study is to see if we can safely regenerate cartilage without invasive surgery using a biologic product called TissueGene-C.

Conditions

  • Osteoarthritis, Knee

Interventions

BIOLOGICAL

TissueGene-C

Single intraarticular injection at 3 x 10e7 cells

DRUG

Normal Saline

Single intraarticular injection of normal saline as a placebo control

Sponsors & Collaborators

  • Kolon TissueGene, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael A Mont, MD · Sinai Hospital of Baltimore

  • David W Romness, MD · Commonwealth Orthopedics, Virginia Hospital Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2013-10-31
Completion
2014-10-31

Countries

  • United States

Study Locations

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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 NCT01221441 on ClinicalTrials.gov