Research
Knee System IDE Clinical Study
Dealing with a knee injury is no walk in the park.
FDA TRIALS
MPA-CARTISTEM-2023-01, Phase 3 FDA Clinical Trial:
Randomized, Prospective, Double Blinded, Multi-Center, Phase 3 Pivotal Clinical Trial to Compare Efficacy and Safety of CARTISTEM and Surgical Comparator in Participants in Knee Osteoarthritis and Cartilage Lesions. TBD/January 2026.
FastTRACK, Hyalofast 15-01, Phase 3 FDA Clinical Trial:
A Prospective, Randomized, Active Treatment-controlled, Evaluator-blinded Multicenter Study to
Establish the Superiority of a Hyaluronan-based Scaffold (Hyalofast) with Autologous Bone Marrow Aspirate Concentrate (BMAC) in the Treatment of Articular Cartilage Defect Lesions in Comparison to Control (Microfracture).
August 2017 – May 2025. Completed.
EPIC-Knee Episealer Knee System IDE, Phase 3 FDA Clinical Trial:
A Prospective, Randomized, Controlled, Multi-Center Study to Evaluate the Safety and Effectiveness of the Episealer Knee System Compared to Microfracture for the Treatment of Focal Femoral Knee Chondral or Osteochondral Lesions.
May 2020 – current.
RECRO, Phase 3B FDA Clinical Trial:
Randomized, Double-Blind, Placebo-Control, Multicenter, Evaluation of the Safety and Efficacy of N1539 Administered Preoperatively in Unilateral Total Knee Arthroplasty. 2018-2019. Completed.
CINGAL, Phase 3 FDA Clinical Trial:
A Prospective Randomized, Controlled, Multi-Center Study of a Single Injection Cross-Linked Sodium Hyaluronate Combined with Triamcinolone Hexacetonide (Cingal) to Provide Symptomatic Relief of Osteoarthritis of the Knee. Completed.
Quest IDE Study, Phase 3 FDA Clinical Trial:
High Frequency Nerve Block for Post-Amputation Pain, NCT 02221934. Completed.
