Stravix / Osiris - LARVOL DELTA

Patient-Reported Erectile Recovery and Quality of Life Outcomes With Lyopreserved Placental Tissue Applied Directly Over Neurovascular Bundle During Nerve Sparing Radical Prostatectomy Versus Standard of Care (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Johns Hopkins University | Trial completion date: Mar 2025 ➔ Dec 2025 | Trial primary completion date: Dec 2024 ➔ Dec 2025

HEOR • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Solid Tumor

AN INJECTABLE NANOFIBER-HYDROGEL-EXOSOME GEL IS EFFECTIVE IN A CROHN'S DISEASE PERIANAL FISTULA MODEL (DDW 2024) - "Rats were then randomized to 5 treatments: (1) standard fistula surgery (brushing of fistula tract followed by closure of internal orifice); ( ) surgery + umbilical cord derived tissue grafts (Stravix) placed into fistula tract (3) surgery +NHC (4) surgery +NHC+ADSCs and (5) surgery +(exo-NHC)... This study demonstrated that exo-NHC platform is a promising approach for perianal fistula treatment in Crohn's disease."

Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease

Patient-Reported Erectile Recovery and Quality of Life Outcomes With Lyopreserved Placental Tissue Applied Directly Over Neurovascular Bundle During Nerve Sparing Radical Prostatectomy Versus Standard of Care (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Johns Hopkins University | Trial completion date: Mar 2024 ➔ Mar 2025 | Trial primary completion date: Dec 2023 ➔ Dec 2024

HEOR • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Cryopreserved vs. Lyopreserved Stravix as an Adjunct to NPWT in the Treatment of Complex Wounds (clinicaltrials.gov) - P4 | N=46 | Completed | Sponsor: University of Texas Southwestern Medical Center | Recruiting ➔ Completed | Trial completion date: Jul 2023 ➔ Jul 2022

Trial completion • Trial completion date

LYOPHILIZED UMBILICAL CORD TISSUE IS EFFECTIVE AS FISTULA PLUG IN A RAT MODEL OF CROHN'S PERIANAL FISTULA (DDW 2022) - "Lyophilized umbilical cord tissue (STRAVIX PL, Smith Nephew) is a nonimmunogenic, biodegradable, biocompatible material obtained from human placenta...This is a promising agent for the treatment of refractory Crohn’s fistula. Further preclinical studies and clinical trials are needed before advancing this technology to patients with Crohn’s and perianal fistulas."

Preclinical • Crohn's disease • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Immune Modulation • Immunology • Pain

"Mit Shah killing it at AUA 2022. Demonstrating our early continence rates for RALPs with stravix @BeaumontUrology @WBHUroResidency #AUA22 #AUA2022" (@BrianOdomMD)

Patient-Reported Erectile Recovery and Quality of Life Outcomes With Lyopreserved Placental Tissue Applied Directly Over Neurovascular Bundle During Nerve Sparing Radical Prostatectomy Versus Standard of Care (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Johns Hopkins University

HEOR • New P2 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Cryopreserved vs. Lyopreserved Stravix as an Adjunct to NPWT in the Treatment of Complex Wounds (clinicaltrials.gov) - P4; N=40; Recruiting; Sponsor: University of Texas Southwestern Medical Center; Not yet recruiting ➔ Recruiting

Clinical • Clinical data • Enrollment open

Cryopreserved vs. Lyopreserved Stravix as an Adjunct to NPWT in the Treatment of Complex Wounds (clinicaltrials.gov) - P4; N=40; Not yet recruiting; Sponsor: University of Texas Southwestern Medical Center; Trial completion date: Jul 2022 ➔ Jul 2023; Initiation date: Jul 2020 ➔ Jan 2021; Trial primary completion date: Jul 2021 ➔ Jul 2022

Clinical • Clinical data • Trial completion date • Trial initiation date • Trial primary completion date

Cryopreserved vs. Lyopreserved Stravix as an Adjunct to NPWT in the Treatment of Complex Wounds (clinicaltrials.gov) - P4; N=40; Not yet recruiting; Sponsor: University of Texas Southwestern Medical Center

Clinical • Clinical data • New P4 trial • Diabetes

PLACENTA DERIVED TISSUE GRAFTS ARE A FEASIBLE ADJUNCT TO THE REPAIR OF RECALCITRANT RECTOVAGINAL FISTULA (SSAT 2020) - "Repair types was based upon surgeon’s choice and StravixÒ Smith-Nephew cryopreserved placental tissue graft was incorporated as in in-lay using a previously reported technique (Ann R Coll Surg Engl...ConclusionCryopreserved placental tissue is a safe adjunct to the repair of RV fistula and may have some efficacy in promoting fistula healing. Futures studies incorporating different fistula type and repair techniques are warranted."

Gastroenterology • Immunology • Inflammatory Bowel Disease

Evaluation of a Novel Hybrid Viable Bioprosthetic Mesh in a Model of Mesh Infection. (PubMed, Plast Reconstr Surg Glob Open) - "Stravix cryopreserved MSC-containing human umbilical tissue does not improve infection resistance of a bioprosthetic mesh in vivo in rats after inoculation with E. coli."

Journal • Biosimilar • Immunology

PLACENTA DERIVED TISSUE GRAFTS ARE A FEASIBLE ADJUNCT TO THE REPAIR OF RECALCITRANT RECTOVAGINAL FISTULA (DDW 2020) - "Repair types was based upon surgeon’s choice and StravixÒ Smith-Nephew cryopreserved placental tissue graft was incorporated as in in-lay using a previously reported technique (Ann R Coll Surg Engl...Conclusion Cryopreserved placental tissue is a safe adjunct to the repair of RV fistula and may have some efficacy in promoting fistula healing. Futures studies incorporating different fistula type and repair techniques are warranted."

Gastroenterology • Immunology • Inflammation • Inflammatory Bowel Disease

A quality improvement pilot assessment of the safety and associated outcomes of a viable cryopreserved umbilical tissue allograft as an adjunct surgical wrap in peroneus brevis tendon repair. (PubMed, Medicine (Baltimore)) - "...Of these available allogeneic biomaterials, the components found in human placental membranes may provide anti-inflammatory, antimicrobial, anti-adhesive, and antifibrotic properties to benefit surgical outcomes.Here, the authors introduce and technically describe the use of a viable cryopreserved umbilical tissue (vCUT) (Stravix, Osiris Therapeutics, Inc., Columbia, MD) as a complementary surgical wrap in primary tendon repair, with particular focus on the peroneus brevis...None of the patients required post-op use of narcotics past day 7. The potential for long-term rehabilitative improvement with adjunct use of vCUT was also demonstrated through reduced pain and reduced transition times to functional and non-assisted ambulation in normal shoewear as compared to historical controls managed without vCUT.This surgical technique is simple and safe for patients and preliminary findings have demonstrated favorable clinical and rehabilitative outcomes over historically..."

Clinical • Journal