Stem Cell Therapy in No Option Chronic Limb-threatening Ischemia
Introduction: Chronic limb-threatening ischemia (CLTI) leads to limb loss in 50% of patients with 20% mortality within 1 year. Patients with advanced disease eventually require major amputation despite currently available revascularization technologies, particularly for those with unsuccessful revas...
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| Format: | Article |
| Language: | English |
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Wolters Kluwer Medknow Publications
2025-04-01
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| Series: | Indian Journal of Vascular and Endovascular Surgery |
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| Online Access: | https://journals.lww.com/10.4103/ijves.ijves_101_24 |
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| author | Yashshwini B Kareti Vinay Kumar Sanjay C Desai Chandrashekar Anagavalli Ramswamy Suhas S Gowda |
| author_facet | Yashshwini B Kareti Vinay Kumar Sanjay C Desai Chandrashekar Anagavalli Ramswamy Suhas S Gowda |
| author_sort | Yashshwini B Kareti |
| collection | DOAJ |
| description | Introduction:
Chronic limb-threatening ischemia (CLTI) leads to limb loss in 50% of patients with 20% mortality within 1 year. Patients with advanced disease eventually require major amputation despite currently available revascularization technologies, particularly for those with unsuccessful revascularization or “no-option” CLTI. Bone marrow-derived mesenchymal stem cells (BM-MSCs) induce angiogenesis, immunomodulation, and regeneration and are safe and effective.
Methods:
A retrospective cohort study was conducted from July 2019 to June 2022 on 14 patients who underwent BM-MSCs implantation of 2 million cells/kg body weight, in gastrocnemius muscle, in 30–70 years age, with 2-year follow-up. Patients with no option for intervention, failed revascularization, and no improvement after being conservatively managed for 45 days were included in the study. Surgically correctable patients were excluded from the study. Descriptive statistics of outcomes of stem cell therapy, primary outcome: amputation-free survival, secondary outcome: pain-free walking distance, wound healing, and objective assessment tests were analyzed, and summarized in percentage. Paired t-tests and P values determined statistical significance.
Results:
The study demonstrated a high amputation-free survival rate of 92.85%, with only one patient requiring amputation during the follow-up period. Significant improvements were observed in secondary outcomes: pain-free walking distance increased substantially (P = 0.0494), ankle–brachial index improved by a mean of 0.15 (P = 0.0005), and transcutaneous oxygen pressure increased by 20–25 mmHg (P = 0.0046). Ulcer healing was remarkable, with 78.5% of patients achieving complete healing by the 2-year follow-up (P = 0.0014). BM-MSC therapy was well-tolerated with minor, transient adverse effects.
Conclusions:
BM-MSC therapy represents a significant advancement for no option CLTI patients. The therapy not only preserves limb function but also enhances quality of life by improving mobility, blood flow, and tissue healing. These promising results underscore the need for larger, randomized controlled trials to confirm the efficacy and long-term benefits of BM-MSC therapy in this high-risk population. |
| format | Article |
| id | doaj-art-e7b5fb8959a048c38ba3e1f1b175f996 |
| institution | DOAJ |
| issn | 0972-0820 2394-0999 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | Wolters Kluwer Medknow Publications |
| record_format | Article |
| series | Indian Journal of Vascular and Endovascular Surgery |
| spelling | doaj-art-e7b5fb8959a048c38ba3e1f1b175f9962025-08-20T03:07:32ZengWolters Kluwer Medknow PublicationsIndian Journal of Vascular and Endovascular Surgery0972-08202394-09992025-04-0112211712110.4103/ijves.ijves_101_24Stem Cell Therapy in No Option Chronic Limb-threatening IschemiaYashshwini B KaretiVinay KumarSanjay C DesaiChandrashekar Anagavalli RamswamySuhas S GowdaIntroduction: Chronic limb-threatening ischemia (CLTI) leads to limb loss in 50% of patients with 20% mortality within 1 year. Patients with advanced disease eventually require major amputation despite currently available revascularization technologies, particularly for those with unsuccessful revascularization or “no-option” CLTI. Bone marrow-derived mesenchymal stem cells (BM-MSCs) induce angiogenesis, immunomodulation, and regeneration and are safe and effective. Methods: A retrospective cohort study was conducted from July 2019 to June 2022 on 14 patients who underwent BM-MSCs implantation of 2 million cells/kg body weight, in gastrocnemius muscle, in 30–70 years age, with 2-year follow-up. Patients with no option for intervention, failed revascularization, and no improvement after being conservatively managed for 45 days were included in the study. Surgically correctable patients were excluded from the study. Descriptive statistics of outcomes of stem cell therapy, primary outcome: amputation-free survival, secondary outcome: pain-free walking distance, wound healing, and objective assessment tests were analyzed, and summarized in percentage. Paired t-tests and P values determined statistical significance. Results: The study demonstrated a high amputation-free survival rate of 92.85%, with only one patient requiring amputation during the follow-up period. Significant improvements were observed in secondary outcomes: pain-free walking distance increased substantially (P = 0.0494), ankle–brachial index improved by a mean of 0.15 (P = 0.0005), and transcutaneous oxygen pressure increased by 20–25 mmHg (P = 0.0046). Ulcer healing was remarkable, with 78.5% of patients achieving complete healing by the 2-year follow-up (P = 0.0014). BM-MSC therapy was well-tolerated with minor, transient adverse effects. Conclusions: BM-MSC therapy represents a significant advancement for no option CLTI patients. The therapy not only preserves limb function but also enhances quality of life by improving mobility, blood flow, and tissue healing. These promising results underscore the need for larger, randomized controlled trials to confirm the efficacy and long-term benefits of BM-MSC therapy in this high-risk population.https://journals.lww.com/10.4103/ijves.ijves_101_24amputation-free survivalankle–brachial indexchronic limb-threatening ischemiastem cell therapytranscutaneous oxygen pressureulcer healing |
| spellingShingle | Yashshwini B Kareti Vinay Kumar Sanjay C Desai Chandrashekar Anagavalli Ramswamy Suhas S Gowda Stem Cell Therapy in No Option Chronic Limb-threatening Ischemia Indian Journal of Vascular and Endovascular Surgery amputation-free survival ankle–brachial index chronic limb-threatening ischemia stem cell therapy transcutaneous oxygen pressure ulcer healing |
| title | Stem Cell Therapy in No Option Chronic Limb-threatening Ischemia |
| title_full | Stem Cell Therapy in No Option Chronic Limb-threatening Ischemia |
| title_fullStr | Stem Cell Therapy in No Option Chronic Limb-threatening Ischemia |
| title_full_unstemmed | Stem Cell Therapy in No Option Chronic Limb-threatening Ischemia |
| title_short | Stem Cell Therapy in No Option Chronic Limb-threatening Ischemia |
| title_sort | stem cell therapy in no option chronic limb threatening ischemia |
| topic | amputation-free survival ankle–brachial index chronic limb-threatening ischemia stem cell therapy transcutaneous oxygen pressure ulcer healing |
| url | https://journals.lww.com/10.4103/ijves.ijves_101_24 |
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