Pivotal Study to Evaluate the Safety and Efficacy of GelrinC for Treatment of Cartilage Defects



Status:Recruiting
Healthy:No
Age Range:18 - 50
Updated:3/16/2019
Start Date:November 14, 2017
End Date:November 2023
Contact:Jonathan Elsner, PhD
Email:jelsner@regentis.co.il
Phone:609 557 7412

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A Prospective, Open-Label, Multicenter Pivotal Study to Evaluate the Safety and Efficacy of GelrinC® for the Treatment of Symptomatic Articular Cartilage Defects of the Femoral Condyle: A Comparison to Historical Control Microfracture

Multicenter, open-label, controlled, non-randomized, double arm trial with a prospective
treatment arm (GelrinC). This study compares the efficacy and safety of GelrinC to a
historical control arm (microfracture) in the treatment of cartilage defects in the knee.


Main Inclusion Criteria:

- Age between 18 and 50.

- Single contained symptomatic lesion located on the femoral condyle of the femur graded
as ICRS III or IV with less than 5 mm of bone loss below the subchondral plate.

- Lesion size between 1 and 5 cm2 post debridement, less than or equal to 2.5 cm in
diameter.

- BMI ≤35

- Contralateral knee is asymptomatic, stable, fully functional and not medically
treated.

Main Exclusion Criteria:

- Presence of an additional grade III or IV symptomatic lesion.

- Recent Osteochondritis Dissecans within 1 year of baseline visit.

- Untreated ACL and/or PCL deficiency or Complex ligamentous instability of the knee.

- Patient is excluded if presenting untreated current meniscal tear or if previous
menisci resection was within the last 6 months.

- Previous tendon repair or ligament reconstruction within the last 6 months.

- Failed Mosaicplasty or ACI or MACI or any other cartilage repair product.

- Microfracture performed less than 1 year before baseline visit.
We found this trial at
13
sites
Savannah, Georgia 31405
Principal Investigator: David Palmer, MD
Phone: 833-430-8686
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Altoona, Pennsylvania 16602
Principal Investigator: Robert J Singer, DO
Phone: 833-430-8686
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Altoona, PA
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Bloomington, Minnesota 55431
Principal Investigator: Brad Nelson, MD
Phone: 833-430-8686
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Bloomington, MN
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Bozeman, Montana 59718
Principal Investigator: Timothy O'Brien, MD
Phone: 833-430-8686
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Bozeman, MT
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Chicago, Illinois 60612
Principal Investigator: Adam Yanke, MD
Phone: 833-430-8686
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Chicago, IL
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Denver, Colorado 80210
Principal Investigator: Rachel Frank, MD
Phone: 833-430-8686
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Denver, CO
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Fort Lauderdale, Florida 33316
Principal Investigator: Kevin Shrock, MD
Phone: 833-430-8686
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Fort Lauderdale, FL
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Gulf Breeze, Florida 32561
Principal Investigator: Christopher O'Grady, MD
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Gulf Breeze, FL
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La Mesa, California 91942
Principal Investigator: Scott Hacker, MD
Phone: 833-430-8686
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La Mesa, CA
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Morrisville, Vermont 05661
Principal Investigator: Bryan Huber, MD
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Morrisville, VT
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Orange, California 92868
Principal Investigator: Robert Grumet, MD
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Orange, CA
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Orlando, Florida 32822
Principal Investigator: Sean McFadden, MD
Phone: 833-430-8686
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Orlando, FL
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Salisbury, Maryland 21804
Principal Investigator: Jason Scopp, MD
Phone: 833-430-8686
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Salisbury, MD
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