ReNu (amniotic suspension allograft) / Organogenesis - LARVOL DELTA

A Study to Evaluate the Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee (clinicaltrials.gov) - P3 | N=594 | Completed | Sponsor: Organogenesis | Active, not recruiting ➔ Completed

Trial completion • Immunology • Osteoarthritis • Pain • Rheumatology

Organogenesis Announces Successful FDA Meeting and Plan to File BLA for ReNu for Knee Osteoarthritis Pain (GlobeNewswire) - "Clinical development program appropriate for rolling BLA. Submission expected by the end of 2025."

FDA event • FDA filing • Osteoarthritis • Pain

A Study to Evaluate the Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee (clinicaltrials.gov) - P3 | N=474 | Active, not recruiting | Sponsor: Organogenesis | Trial completion date: Mar 2026 ➔ Nov 2025

Trial completion date • Immunology • Osteoarthritis • Pain • Rheumatology

Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee (clinicaltrials.gov) - P3 | N=516 | Completed | Sponsor: Organogenesis | Active, not recruiting ➔ Completed

Trial completion • Immunology • Osteoarthritis • Pain • Rheumatology

Organogenesis Holdings Inc…announced that the second Phase 3 randomized controlled trial (RCT) of ReNu, a cryopreserved amniotic suspension allograft (ASA) for the management of symptoms associated with knee osteoarthritis (OA), did not achieve statistical significance for its primary endpoint (Organogenesis) - "Baseline pain reduction at six months for ReNu was -6.9 for the second Phase 3 study compared to -6.0 in the first Phase 3 study. Additionally, the ReNu results continued to demonstrate a favorable safety profile...The study demonstrated a numerical improvement of -0.51 favoring ReNu (p=0.0393 one-sided p-value, compared to p=0.023 target threshold). The first Phase 3 trial achieved improvement of -0.72 favoring ReNu, which was statistically significant (p=0.0177, one sided p-value, compared to p=0.023 target threshold)....'As a next step, we will request a pre-BLA meeting with the FDA by the end of October to discuss the submission pathway'"

FDA event • P3 data • Inflammation • Osteoarthritis • Pain

A Study to Evaluate the Efficacy of Amniotic Suspension Allograft in Patients with Osteoarthritis of the Knee (clinicaltrials.gov) - P3 | N=474 | Active, not recruiting | Sponsor: Organogenesis | Recruiting ➔ Active, not recruiting

Enrollment closed • Immunology • Osteoarthritis • Pain • Rheumatology

Efficacy of Amniotic Suspension Allograft in Patients with Osteoarthritis of the Knee (clinicaltrials.gov) - P3 | N=474 | Active, not recruiting | Sponsor: Organogenesis | Trial completion date: Mar 2024 ➔ Jun 2025

Trial completion date • Immunology • Osteoarthritis • Pain • Rheumatology

Effect of amniotic suspension allograft in a rat destabilization of medial meniscus osteoarthritis model. (PubMed, J Orthop Res) - "When comparing the impact of single and repeat ASA treatments on behavioral testing, repeated injection provided significant additional improvements in both pain and function. This study provides evidence demonstrating the impact of a second injection while also providing additional data for evaluating the use of ASA as a nonsurgical treatment for knee OA."

Journal • Preclinical • Immunology • Osteoarthritis • Pain • Rheumatology

Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee (clinicaltrials.gov) - P3 | N=474 | Active, not recruiting | Sponsor: Organogenesis | Trial completion date: Dec 2023 ➔ Mar 2024

Trial completion date • Immunology • Osteoarthritis • Pain • Rheumatology

A Study to Evaluate the Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee (clinicaltrials.gov) - P3 | N=474 | Recruiting | Sponsor: Organogenesis

Trial completion date • Trial primary completion date • Immunology • Osteoarthritis • Pain • Rheumatology

A Study to Evaluate the Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee (clinicaltrials.gov) - P3 | N=474 | Recruiting | Sponsor: Organogenesis | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Osteoarthritis • Pain • Rheumatology