PMID- 37373842
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230701
IS  - 2077-0383 (Print)
IS  - 2077-0383 (Electronic)
IS  - 2077-0383 (Linking)
VI  - 12
IP  - 12
DP  - 2023 Jun 20
TI  - Autologous Peripheral Blood Mononuclear Cells in Patients with Small Artery 
      Disease and Diabetic Foot Ulcers: Efficacy, Safety, and Economic Evaluation.
LID - 10.3390/jcm12124148 [doi]
LID - 4148
AB  - BACKGROUND: diabetic foot ulcers (DFU) represent the main cause of major 
      amputations and hospitalisations in diabetic patients. The aim of this study was 
      to assess the safety and cost-efficacy of intramuscular injection of peripheral 
      blood mononuclear cells (PBMNCs) in diabetic patients with no-option chronic 
      limb-threatening ischemia (CLTI) and small artery disease (SAD). METHODS: a 
      retrospective study was carried out on a series of type 2 diabetic patients with 
      DFU grade Texas 3 and no-option CLTI and SAD. All patients had undergone at least 
      a previous revascularization and were allocated to a surgery waiting list for 
      major amputation. The principal endpoint evaluated at 90 days was a composite of 
      TcPO(2) values at the first toe >/=30 mmHg and/or TcPO(2) increase of at least 50% 
      from baseline and/or ulcer healing. Secondary endpoints were individual 
      components of the primary endpoint, any serious and non-serious adverse events, 
      and direct costs at one year. RESULTS: the composite endpoint was achieved in 
      nine patients (60.0%); one patient (6.7%) healed within ninety days and 26.7% and 
      46.7% showed TcPO(2) >/= 30 mmHg and a TcPO(2) increase of at least 50% at ninety 
      days, respectively. At one year, three (20.0%) patients underwent a major 
      amputation (all diagnosed SAD grade III). One patient died after seven months, 
      and seven patients (46.7%) healed. The overall median and mean cost per patient 
      were EUR 8238 +/- 7798 and EUR 4426 (3798; 8262), respectively. CONCLUSIONS: the 
      use of PBMNCs implants in no-option CLTI diabetic patients with SAD seems to be 
      of help in reducing the risk of major amputation.
FAU - Ragghianti, Benedetta
AU  - Ragghianti B
AD  - Department of Diabetology, Careggi University Hospital, 50121 Florence, Italy.
FAU - Berardi, Bianca Maria
AU  - Berardi BM
AD  - Department of Diabetology, Careggi University Hospital, 50121 Florence, Italy.
FAU - Mannucci, Edoardo
AU  - Mannucci E
AD  - Department of Diabetology, Careggi University Hospital, 50121 Florence, Italy.
FAU - Monami, Matteo
AU  - Monami M
AUID- ORCID: 0000-0001-9349-828X
AD  - Department of Diabetology, Careggi University Hospital, 50121 Florence, Italy.
LA  - eng
PT  - Journal Article
DEP - 20230620
PL  - Switzerland
TA  - J Clin Med
JT  - Journal of clinical medicine
JID - 101606588
PMC - PMC10298945
OTO - NOTNLM
OT  - cell therapy
OT  - chronic limb-threatening ischemia
OT  - diabetes mellitus
OT  - economic evaluation
OT  - foot ulcer
OT  - small artery disease
COIS- The authors declare no conflict of interest.
EDAT- 2023/06/28 06:42
MHDA- 2023/06/28 06:43
PMCR- 2023/06/20
CRDT- 2023/06/28 01:23
PHST- 2023/05/12 00:00 [received]
PHST- 2023/06/12 00:00 [revised]
PHST- 2023/06/18 00:00 [accepted]
PHST- 2023/06/28 06:43 [medline]
PHST- 2023/06/28 06:42 [pubmed]
PHST- 2023/06/28 01:23 [entrez]
PHST- 2023/06/20 00:00 [pmc-release]
AID - jcm12124148 [pii]
AID - jcm-12-04148 [pii]
AID - 10.3390/jcm12124148 [doi]
PST - epublish
SO  - J Clin Med. 2023 Jun 20;12(12):4148. doi: 10.3390/jcm12124148.