PMID- 32386343
OWN - NLM
STAT- MEDLINE
DCOM- 20210721
LR  - 20221207
IS  - 1524-475X (Electronic)
IS  - 1067-1927 (Print)
IS  - 1067-1927 (Linking)
VI  - 28
IP  - 4
DP  - 2020 Jul
TI  - One-year safety, healing and amputation rates of Wagner 3-4 diabetic foot ulcers 
      treated with cryopreserved umbilical cord (TTAX01).
PG  - 526-531
LID - 10.1111/wrr.12809 [doi]
AB  - An open label, multicenter 16-week trial of cryopreserved human umbilical cord 
      (TTAX01) was previously undertaken in 32 subjects presenting with a Wagner grade 
      3 or 4 diabetic foot ulcer, with 16 (50%) of these having confirmed closure 
      following a median of one product application (previous study). All but two 
      subjects (30/32; 94%) consented to participate in this follow-up study to 1-year 
      postexposure. No restrictions were placed on treatments for open wounds. At 
      8-week intervals, subjects were evaluated for adverse events (AEs) and wound 
      status (open or closed). Average time from initial exposure to end of follow-up 
      was 378 days (range 343-433), with 29 of 30 (97%) subjects completing a full 
      year. AEs were all typical for the population under study, and none were 
      attributed to prior exposure to TTAX01. One previously healed wound re-opened, 
      one previously unconfirmed closed wound remained healed, and nine new wound 
      closures occurred, giving 25 of 29 (86.2%) healed in the ITT population. Three of 
      the new closures followed the use of various tissue-based products. Three 
      subjects whose wounds were healed required subsequent minor amputations due to 
      osteomyelitis, one of which progressed to a major amputation (1/29; 3.4%). 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.
CI  - (c) 2020 The Authors. Wound Repair and Regeneration published by Wiley Periodicals, 
      Inc. on behalf of by the Wound Healing Society.
FAU - Marston, William A
AU  - Marston WA
AD  - Division of Vascular Surgery, University of North Carolina School of Medicine, 
      Chapel Hill, North Carolina, USA.
FAU - Lantis, John C 2nd
AU  - Lantis JC 2nd
AD  - Mt Sinai West and St Luke's Hospitals, New York, New York, USA.
FAU - Wu, Stephanie C
AU  - Wu SC
AD  - Rosalind Franklin University, North Chicago, Illinois, USA.
FAU - Nouvong, Aksone
AU  - Nouvong A
AUID- ORCID: 0000-0001-9904-6065
AD  - Department of Surgery, UCLA, Los Angeles, California, USA.
FAU - Clements, John Randolph
AU  - Clements JR
AD  - Carilion Clinic, Roanoke, Virginia, USA.
FAU - Lee, Tommy D
AU  - Lee TD
AD  - TissueTech, Inc., Miami, Florida, USA.
FAU - McCoy, Nicholas D
AU  - McCoy ND
AD  - TissueTech, Inc., Miami, Florida, USA.
FAU - Slade, Herbert B
AU  - Slade HB
AUID- ORCID: 0000-0002-0550-8757
AD  - TissueTech, Inc., Miami, Florida, USA.
AD  - Department of Pediatrics, University of North Texas Health Sciences Center, Fort 
      Worth, Texas, USA.
FAU - Tseng, Scheffer C
AU  - Tseng SC
AD  - TissueTech, Inc., Miami, Florida, USA.
LA  - eng
PT  - Journal Article
DEP - 20200509
PL  - United States
TA  - Wound Repair Regen
JT  - Wound repair and regeneration : official publication of the Wound Healing Society 
      [and] the European Tissue Repair Society
JID - 9310939
RN  - 0 (Biological Products)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Amputation, Surgical/statistics & numerical data
MH  - Biological Products/*therapeutic use
MH  - *Cryopreservation
MH  - Diabetic Foot/*therapy
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Severity of Illness Index
MH  - Treatment Outcome
MH  - Umbilical Cord/*transplantation
MH  - *Wound Healing
PMC - PMC7383512
EDAT- 2020/05/10 06:00
MHDA- 2021/07/22 06:00
PMCR- 2020/07/27
CRDT- 2020/05/10 06:00
PHST- 2020/01/15 00:00 [received]
PHST- 2020/02/09 00:00 [revised]
PHST- 2020/03/10 00:00 [accepted]
PHST- 2020/05/10 06:00 [pubmed]
PHST- 2021/07/22 06:00 [medline]
PHST- 2020/05/10 06:00 [entrez]
PHST- 2020/07/27 00:00 [pmc-release]
AID - WRR12809 [pii]
AID - 10.1111/wrr.12809 [doi]
PST - ppublish
SO  - Wound Repair Regen. 2020 Jul;28(4):526-531. doi: 10.1111/wrr.12809. Epub 2020 May 
      9.