Autologous Peripheral Blood Mononuclear Cells in Patients with Small Artery Disease and Diabetic Foot Ulcers: Efficacy, Safety, and Economic Evaluation
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-opti...
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| Format: | Article |
| Language: | English |
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MDPI AG
2023-06-01
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| Series: | Journal of Clinical Medicine |
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| Online Access: | https://www.mdpi.com/2077-0383/12/12/4148 |
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| author | Benedetta Ragghianti Bianca Maria Berardi Edoardo Mannucci Matteo Monami |
| author_facet | Benedetta Ragghianti Bianca Maria Berardi Edoardo Mannucci Matteo Monami |
| author_sort | Benedetta Ragghianti |
| collection | DOAJ |
| description | 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<sub>2</sub> values at the first toe ≥30 mmHg and/or TcPO<sub>2</sub> 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<sub>2</sub> ≥ 30 mmHg and a TcPO<sub>2</sub> 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. |
| first_indexed | 2024-03-11T02:18:52Z |
| format | Article |
| id | doaj.art-db3299c72de049ed899fd4e9428262f5 |
| institution | Directory Open Access Journal |
| issn | 2077-0383 |
| language | English |
| last_indexed | 2024-03-11T02:18:52Z |
| publishDate | 2023-06-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Journal of Clinical Medicine |
| spelling | doaj.art-db3299c72de049ed899fd4e9428262f52023-11-18T11:01:39ZengMDPI AGJournal of Clinical Medicine2077-03832023-06-011212414810.3390/jcm12124148Autologous Peripheral Blood Mononuclear Cells in Patients with Small Artery Disease and Diabetic Foot Ulcers: Efficacy, Safety, and Economic EvaluationBenedetta Ragghianti0Bianca Maria Berardi1Edoardo Mannucci2Matteo Monami3Department of Diabetology, Careggi University Hospital, 50121 Florence, ItalyDepartment of Diabetology, Careggi University Hospital, 50121 Florence, ItalyDepartment of Diabetology, Careggi University Hospital, 50121 Florence, ItalyDepartment of Diabetology, Careggi University Hospital, 50121 Florence, ItalyBackground: 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<sub>2</sub> values at the first toe ≥30 mmHg and/or TcPO<sub>2</sub> 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<sub>2</sub> ≥ 30 mmHg and a TcPO<sub>2</sub> 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.https://www.mdpi.com/2077-0383/12/12/4148diabetes mellitusfoot ulcercell therapysmall artery diseasechronic limb-threatening ischemiaeconomic evaluation |
| spellingShingle | Benedetta Ragghianti Bianca Maria Berardi Edoardo Mannucci Matteo Monami Autologous Peripheral Blood Mononuclear Cells in Patients with Small Artery Disease and Diabetic Foot Ulcers: Efficacy, Safety, and Economic Evaluation Journal of Clinical Medicine diabetes mellitus foot ulcer cell therapy small artery disease chronic limb-threatening ischemia economic evaluation |
| title | Autologous Peripheral Blood Mononuclear Cells in Patients with Small Artery Disease and Diabetic Foot Ulcers: Efficacy, Safety, and Economic Evaluation |
| title_full | Autologous Peripheral Blood Mononuclear Cells in Patients with Small Artery Disease and Diabetic Foot Ulcers: Efficacy, Safety, and Economic Evaluation |
| title_fullStr | Autologous Peripheral Blood Mononuclear Cells in Patients with Small Artery Disease and Diabetic Foot Ulcers: Efficacy, Safety, and Economic Evaluation |
| title_full_unstemmed | Autologous Peripheral Blood Mononuclear Cells in Patients with Small Artery Disease and Diabetic Foot Ulcers: Efficacy, Safety, and Economic Evaluation |
| title_short | Autologous Peripheral Blood Mononuclear Cells in Patients with Small Artery Disease and Diabetic Foot Ulcers: Efficacy, Safety, and Economic Evaluation |
| title_sort | autologous peripheral blood mononuclear cells in patients with small artery disease and diabetic foot ulcers efficacy safety and economic evaluation |
| topic | diabetes mellitus foot ulcer cell therapy small artery disease chronic limb-threatening ischemia economic evaluation |
| url | https://www.mdpi.com/2077-0383/12/12/4148 |
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