TTAX01 / BioTissue - LARVOL DELTA

A Multi-Centre, Randomised, Controlled Clinical Trial Assessing Cryopreserved Ultra-Thick Human Amniotic Membrane in the Treatment of Complex Diabetic Foot Ulcers. (PubMed, Wound Repair Regen) - "TTAX01/Neox 1K are cryopreserved ultra-thick human amniotic membrane products derived from umbilical cord (cUC) that have been assessed for clinical effectiveness in complex diabetic foot ulcers (DFUs)...Adverse event rates, i.e., 89.8% and 87.3%, were comparable between cUC and SOC groups. While there were no significant differences in healing rates or adverse events between the two treatment arms at any time point, this study demonstrates that adjunctive cUC is safe and helps achieve a high healing rate at 50 weeks with less than four applications for complex DFUs that are often excluded in clinical trials."

Clinical • Journal • Inflammation

Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU II) (clinicaltrials.gov) - P3 | N=106 | Completed | Sponsor: BioTissue Holdings, Inc | Active, not recruiting ➔ Completed | N=220 ➔ 106

Enrollment change • Trial completion • Infectious Disease

Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU II) (clinicaltrials.gov) - P3 | N=220 | Active, not recruiting | Sponsor: BioTissue Holdings, Inc | Recruiting ➔ Active, not recruiting | Trial completion date: Sep 2024 ➔ Mar 2025 | Trial primary completion date: Sep 2024 ➔ Mar 2025

Enrollment closed • Trial completion date • Trial primary completion date • Infectious Disease

Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU) (clinicaltrials.gov) - P3 | N=220 | Completed | Sponsor: Tissue Tech Inc. | Active, not recruiting ➔ Completed | Trial primary completion date: Jul 2024 ➔ Jan 2024

Trial completion • Trial primary completion date • Infectious Disease

Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU II) (clinicaltrials.gov) - P3 | N=220 | Recruiting | Sponsor: Tissue Tech Inc.

Trial completion date • Infectious Disease

Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU) (clinicaltrials.gov) - P3 | N=220 | Active, not recruiting | Sponsor: Tissue Tech Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Apr 2023 ➔ Jul 2024 | Trial primary completion date: Feb 2023 ➔ Jul 2024

Enrollment closed • Trial completion date • Trial primary completion date • Infectious Disease

Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU II) (clinicaltrials.gov) - P3 | N=220 | Recruiting | Sponsor: Tissue Tech Inc. | Trial completion date: Jul 2023 ➔ Sep 2024 | Trial primary completion date: Apr 2023 ➔ Sep 2024

Trial completion date • Trial primary completion date • Infectious Disease

Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU II) (clinicaltrials.gov) - P3; N=220; Recruiting; Sponsor: Tissue Tech Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

An open label trial of cryopreserved human umbilical cord in the treatment of complex diabetic foot ulcers complicated by osteomyelitis. (PubMed, Wound Repair Regen) - "An open-label, multicenter trial of cryopreserved human umbilical cord (TTAX01) was undertaken in 32 subjects presenting with such complex wounds with a mean duration of 6.1 ± 9.0 (range: 0.2-47.1) months and wound area at screening of 3.8 ± 2.9 (range: 1.0-9.6) cm...The product was well tolerated. Two minor amputations occurred during the study period due to recurrent or persistent osteomyelitis, but there were no major amputations."

Clinical • Journal • CNS Disorders

Subjects With Non-Healing Venous Leg Ulcers Treated With Standard Care Plus Cryopreserved Human Umbilical Cord (TTAX01) (clinicaltrials.gov) - P2; N=31; Completed; Sponsor: Tissue Tech Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Venous Ulcer

Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU) (clinicaltrials.gov) - P3; N=220; Recruiting; Sponsor: Tissue Tech Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU II) (clinicaltrials.gov) - P3; N=220; Not yet recruiting; Sponsor: Tissue Tech Inc.

Clinical • New P3 trial

One-year safety, healing and amputation rates of Wagner 3-4 diabetic foot ulcers treated with cryopreserved umbilical cord (TTAX01). (PubMed, Wound Repair Regen) - "One additional subject underwent two minor amputations prior to healing. Overall, the study found TTAX01 to be safe in long-term follow-up and associated with both a low rate of major amputation and a higher than expected rates of healing."

Clinical • Journal

Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU) (clinicaltrials.gov) - P3; N=220; Not yet recruiting; Sponsor: Tissue Tech Inc.; Trial completion date: Sep 2022 ➔ Apr 2023; Initiation date: Mar 2020 ➔ Jul 2020; Trial primary completion date: Jul 2022 ➔ Feb 2023

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