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Trial completion, Trial primary completion date: Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU) (clinicaltrials.gov) - Jun 13, 2024
P3, N=220, Completed, Sponsor: Tissue Tech Inc.
Active, not recruiting --> Completed | Trial primary completion date: Jul 2024 --> Jan 2024
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Trial completion date, Trial primary completion date: Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU II) (clinicaltrials.gov) - Dec 8, 2023
P3, N=220, Recruiting, Sponsor: Tissue Tech Inc.
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Trial completion date, Trial primary completion date: Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU II) (clinicaltrials.gov) - Sep 13, 2023
P3, N=220, Recruiting, Sponsor: Tissue Tech Inc.
Active, not recruiting --> Completed | Trial primary completion date: Jul 2024 --> Jan 2024 Trial completion date: Jul 2023 --> Sep 2024 | Trial primary completion date: Apr 2023 --> Sep 2024
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Enrollment closed, Trial completion date, Trial primary completion date: Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU) (clinicaltrials.gov) - Sep 13, 2023
P3, N=220, Active, not recruiting, Sponsor: Tissue Tech Inc.
Trial completion date: Jul 2023 --> Sep 2024 | Trial primary completion date: Apr 2023 --> Sep 2024 Recruiting --> Active, not recruiting | Trial completion date: Apr 2023 --> Jul 2024 | Trial primary completion date: Feb 2023 --> Jul 2024
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Clinical, Journal: One-year safety, healing and amputation rates of Wagner 3-4 diabetic foot ulcers treated with cryopreserved umbilical cord (TTAX01). (Pubmed Central) - Jul 23, 2021
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.
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Enrollment open: Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU II) (clinicaltrials.gov) - Nov 23, 2020
P3, N=220, Recruiting, Sponsor: Tissue Tech Inc.
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. Not yet recruiting --> Recruiting
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Clinical, Journal: An open label trial of cryopreserved human umbilical cord in the treatment of complex diabetic foot ulcers complicated by osteomyelitis. (Pubmed Central) - Sep 27, 2020
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.
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Trial completion: Subjects With Non-Healing Venous Leg Ulcers Treated With Standard Care Plus Cryopreserved Human Umbilical Cord (TTAX01) (clinicaltrials.gov) - Aug 31, 2020
P2, N=31, Completed, Sponsor: Tissue Tech Inc.
Two minor amputations occurred during the study period due to recurrent or persistent osteomyelitis, but there were no major amputations. Active, not recruiting --> Completed
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Enrollment open: Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU) (clinicaltrials.gov) - Jul 7, 2020
P3, N=220, Recruiting, Sponsor: Tissue Tech Inc.
Active, not recruiting --> Completed Not yet recruiting --> Recruiting
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New P3 trial: Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU II) (clinicaltrials.gov) - Jun 28, 2020
P3, N=220, Not yet recruiting, Sponsor: Tissue Tech Inc.
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Clinical: One-year Safety, Healing and Amputation Rates of Wagner 3-4 Diabetic Foot Ulcers Treated With Cryopreserved Umbilical Cord (TTAX01) - PubMed https://t.co/PGBm699VcS (Twitter) - May 10, 2020
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Trial completion date, Trial initiation date, Trial primary completion date: Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU) (clinicaltrials.gov) - Apr 13, 2020
P3, N=220, Not yet recruiting, Sponsor: Tissue Tech Inc.
Not yet recruiting --> Recruiting Trial completion date: Sep 2022 --> Apr 2023 | Initiation date: Mar 2020 --> Jul 2020 | Trial primary completion date: Jul 2022 --> Feb 2023
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New P3 trial: Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU) (clinicaltrials.gov) - Nov 24, 2019
P3, N=250, Not yet recruiting, Sponsor: Tissue Tech Inc.
- | TTAX01 / Tissuetech
Trial primary completion date: Subjects With Non-Healing Venous Leg Ulcers Treated With Standard Care Plus Cryopreserved Human Umbilical Cord (TTAX01) (clinicaltrials.gov) - Sep 30, 2019
P2, N=35, Active, not 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 Trial primary completion date: Sep 2019 --> Jan 2020
- | TTAX01 / Tissuetech
Enrollment closed: Subjects With Non-Healing Venous Leg Ulcers Treated With Standard Care Plus Cryopreserved Human Umbilical Cord (TTAX01) (clinicaltrials.gov) - Sep 29, 2019
P2, N=35, Active, not recruiting, Sponsor: Tissue Tech Inc.
Trial primary completion date: Sep 2019 --> Jan 2020 Recruiting --> Active, not recruiting
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Trial completion: Phase 2 Pilot Trial of Subjects With Complex Non-healing Diabetic Foot Ulcers Treated With Standard Care Plus Cryopreserved Umbilical Cord Allograft (TTAX01) (clinicaltrials.gov) - Jun 3, 2019
P2, N=32, Completed, Sponsor: Tissue Tech Inc.
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
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Enrollment open: Subjects With Non-Healing Venous Leg Ulcers Treated With Standard Care Plus Cryopreserved Human Umbilical Cord (TTAX01) (clinicaltrials.gov) - Feb 18, 2019
P2, N=35, Recruiting, Sponsor: Tissue Tech Inc.
Active, not recruiting --> Completed Not yet recruiting --> Recruiting
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New P2 trial: Subjects With Non-Healing Venous Leg Ulcers Treated With Standard Care Plus Cryopreserved Human Umbilical Cord (TTAX01) (clinicaltrials.gov) - Jan 28, 2019
P2, N=35, Not yet recruiting, Sponsor: Tissue Tech Inc.
- | TTAX01 / BioTissue
Enrollment closed, Trial completion date, Trial primary completion date: Phase 2 Pilot Trial of Subjects With Complex Non-healing Diabetic Foot Ulcers Treated With Standard Care Plus Cryopreserved Umbilical Cord Allograft (TTAX01) (clinicaltrials.gov) - Sep 11, 2018
P2, N=32, Active, not recruiting, Sponsor: Tissue Tech Inc.
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting | Trial completion date: Jun 2018 --> Mar 2019 | Trial primary completion date: Jun 2018 --> Dec 2018
- | TTAX01 / BioTissue
Enrollment open: Phase 2 Pilot Trial of Subjects With Complex Non-healing Diabetic Foot Ulcers Treated With Standard Care Plus Cryopreserved Umbilical Cord Allograft (TTAX01) (clinicaltrials.gov) - Oct 10, 2017
P2, N=30, Recruiting, Sponsor: Tissue Tech Inc.
Recruiting --> Active, not recruiting | Trial completion date: Jun 2018 --> Mar 2019 | Trial primary completion date: Jun 2018 --> Dec 2018 Not yet recruiting --> Recruiting
- | TTAX01 / BioTissue
New P2 trial: Phase 2 Pilot Trial of Subjects With Complex Non-healing Diabetic Foot Ulcers Treated With Standard Care Plus Cryopreserved Umbilical Cord Allograft (TTAX01) (clinicaltrials.gov) - Jul 25, 2017
P2, N=30, Not yet recruiting, Sponsor: Tissue Tech Inc.