Therapeutic Efficacy of Autologous Non-Mobilized Enriched Circulating Endothelial Progenitors in Patients With Critical Limb Ischemia　― The SCELTA Trial ―

Liotta, Francesco; Annunziato, Francesco; Castellani, Sergio; Boddi, Maria; Alterini, Brunetto; Castellini, Giovanni; Mazzanti, Benedetta; Cosmi, Lorenzo; Acquafresca, Manlio; Bartalesi, Filippo; Dilaghi, Beatrice; Dorigo, Walter; Graziani, G; Bartolozzi, Benedetta; Bellandi, Guido; Carli, G; Bartoloni, Alessandro; Fargion, Aaron; Fassio, Filippo; Fontanari, Paolo; Landini, Giancarlo; Lucente, E; Michelagnoli, Stefano; Battaglini, Carolina Orsi; Panigada, Grazia; Pigozzi, Clara; Querci, Valentina; Santarlasci, Veronica; Parronchi, Paola; Troisi, Nicola; Baggiore, Cristiana; Romagnani, Paola; Mannucci, Edoardo; Saccardi, Riccardo; Pratesi, Carlo; Gensini, Gianfranco; Romagnani, Sergio; Maggi, Enrico

doi:10.1253/circj.cj-17-0720

Cited by 30 publications

(32 citation statements)

References 43 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…It has been reported that one method among the cell therapies that promote peripheral circulation is therapeutic angiogenesis using bone marrow-derived mononuclear cells (BM-MNC). [8][9][10] The first clinical pilot study, Therapeutic Angiogenesis by Cell Transplantation (TACT) study, investigated this in CLI patients in 2002, 11 and subsequently, several studies have reported the safety and efficacy of BM-MNC implantation for CLI patients. 12,13 Randomized studies have reported that this cell therapy could lead to significant improvements in limb ischemia, thus extending amputation-free intervals and survival rates.…”

Section: Study Populationmentioning

confidence: 99%

Impact of Therapeutic Angiogenesis Using Autologous Bone Marrow-Derived Mononuclear Cells Implantation in Critical Limb Ischemia With Scleroderma　― Subanalysis of the Long-Term Clinical Outcomes Survey ―

Kudoh

Yanishi

Yoshimi

et al. 2019

Circ J

View full text Add to dashboard Cite

CD, particularly with systemic sclerosis (SSc, scleroderma) have experienced Raynaud's phenomenon or digital ulcers (DU) because of inadequate peripheral blood supply. Intractable ischemic ulcers negatively affect patients' quality of life (QOL), and may lead to limb amputation. 2 The European League against Rheumatism (EULAR) recommends intravenous (IV) iloprost, PDE-5 inhibitors, and C ritical limb ischemia (CLI) is caused by chronic arterial obstruction, mainly caused by arteriosclerosis obliterans (ASO), thromboangiitis obliterans (TAO), and collagen disease (CD). Patients with CLI often require limb amputation when conventional revascularization methods such as bypass surgery or endovascular treatment (EVT) fail or are not indicated. 1 Patients with

show abstract

Section: Study Populationmentioning

confidence: 99%

Impact of Therapeutic Angiogenesis Using Autologous Bone Marrow-Derived Mononuclear Cells Implantation in Critical Limb Ischemia With Scleroderma　― Subanalysis of the Long-Term Clinical Outcomes Survey ―

Kudoh

Yanishi

Yoshimi

et al. 2019

Circ J

View full text Add to dashboard Cite

show abstract

“…Several previous studies have demonstrated PBDSCs transplantation presented similar outcomes with BMDSCs on limb salvage [18,24,25]. However, the sample size was relatively small whether in RCT or single-arm studies [26][27][28][29]. To our knowledge, the current series represents the largest number of patients with AICLI treated by PBDSCs transplantation in a single center.…”

Section: Discussionmentioning

confidence: 84%

Autologous Peripheral Blood-derived Stem Cells Transplantation for Treatment of no-option Angiitis-induced Critical Limb Ischemia: 10-year Management Experience

Fang

Jiang

Fang

et al. 2020

Preprint

View full text Add to dashboard Cite

Background: Previous studies have demonstrated that no-option angiitis-induced critical limb ischemia (NO-AICLI) could be significantly improved by transplantation of peripheral blood-derived stem cells (PBDSCs). Additionally, a randomized controlled trial (RCT) recently conducted by us suggested that peripheral blood-derived purified CD34+ cells (PCCs) were not inferior to non-purified peripheral blood mononuclear cells (PBMNCs) at limb salvage in treatment of NO-AICLI. However, most of these clinical trials whether RCT or single-arm studies were characterized with a small sample size and absence of long-term outcomes. Methods: To analyze long-term clinical outcomes of PBDSCs transplantation for NO-AICLI, we reviewed clinical data of patients with NO-AICLI receiving PBDSCs transplantation at our center during the past decade. Meanwhile, we first compared the long-term safety and efficacy of intramuscular transplantation of PCCs versus PBMNCs in a sizable number of patients with NO-AICLI.Results: From May 2009 to December 2019, a total of 160 patients with NO-AICLI patients were treated by PBDSCs transplantation (82 with PCCs, 78 with PBMNCs) at our center. Baseline characteristics between two groups were similar. Up to June 2020, the mean follow-up period was 46.6±35.3 months. No critical adverse events were observed in either group. There was one death during the follow-up period. A total of eight major amputations occurred. The cumulative major amputation-free survival (MAFS) rate at 5 years after PBDSCs transplantation was 94.4%, without difference between two groups (P=.855). Wound healing, rest pain, pain-free walking time, ankle-brachial index, transcutaneous oxygen pressure, and quality of life (QoL) also significantly improved after PBDSCs transplantation. Conclusions: Autologous PBDSCs intramuscular transplantation could significantly decrease the major amputation rates and improve the QoL in patients with NO-AICLI. Long-term observation of a large sample of patients confirmed that the clinical benefits of PBDSCs transplantation were durable, without difference between the PCCs and PBMNCs groups.

show abstract

“…The selective ltration based technology we used produces an autologous cell concentrate wich contains PB-MNCs plus 1% around of CD34+ [13]. Despite the e ciency in CD34 + hematopoietic stem cell enrichment with the use of Bone Marrow Point of Care system is comparable to the enrichment obtained by Pall Celeris system [62], several studies showed that limb savage was not correlated to CD34 + concentration [16,48,63,64].…”

Section: Discussionmentioning

confidence: 99%

The use of Peripheral Blood-Mononuclear Cells in Scleroderma patients: an observational preliminary study

Carella

Rossi

Ribuffo

et al. 2020

Preprint

View full text Add to dashboard Cite

Background Systemic sclerosis (SSc) is a systemic autoimmune disease characterized by vasculopathy and excessive production of collagen, which lead to skin and visceral fibrosis. The aim of our study is to assess the potential benefits of peripheral blood mononuclear cells (PB-MNCs) implants in the treatment of clinical manifestations such as mouth impairment, hand disability, digital ulcers and Raynaud’s phenomenon in Scleroderma patients. Methods From February 2016 to May 2019, 10 female patients were enrolled from the outpatient clinic of the Plastic Surgery Unit of Sapienza University of Rome. Parameters evaluated were: patients’ disability, using the Health Assessment Questionnaire (HAQ) disability index (DI) and the scleroderma HAQ (sHAQ); mouth opening capacity, by measuring the maximum interincisal distance and the mouth perimeter; hand mobility, assessed with clinical exam and the Hand Mobility in Scleroderma (HAMIS) scale; Raynaud’s phenomenon, evaluated through nailfold capillaroscopy; digital ulcers, examined through their features and incidence of appearance. SPSS software was used for a simple descriptive statistical analysis performed by the Student's paired t-test. P values less than 0.05 were considered statistically significant. Results The treatment showed a significant improvement of all the parameters evaluated at 1-year follow-up, it was well-tolerated by all the patients and the only complications noticed were small areas of ecchymosis. Conclusions Our results suggest that PB-MNCs injection could represent a treatment option to take into account for SSc patients. The procedure we used is easy and fast to perform, minimally invasive and not-operator dependent. We hope our observational and preliminary study could be considered as a starting point for further research studies.

show abstract

Therapeutic Efficacy of Autologous Non-Mobilized Enriched Circulating Endothelial Progenitors in Patients With Critical Limb Ischemia　― The SCELTA Trial ―

Cited by 30 publications

References 43 publications

Impact of Therapeutic Angiogenesis Using Autologous Bone Marrow-Derived Mononuclear Cells Implantation in Critical Limb Ischemia With Scleroderma　― Subanalysis of the Long-Term Clinical Outcomes Survey ―

Impact of Therapeutic Angiogenesis Using Autologous Bone Marrow-Derived Mononuclear Cells Implantation in Critical Limb Ischemia With Scleroderma　― Subanalysis of the Long-Term Clinical Outcomes Survey ―

Autologous Peripheral Blood-derived Stem Cells Transplantation for Treatment of no-option Angiitis-induced Critical Limb Ischemia: 10-year Management Experience

The use of Peripheral Blood-Mononuclear Cells in Scleroderma patients: an observational preliminary study

Contact Info

Product

Resources

About

Therapeutic Efficacy of Autologous Non-Mobilized Enriched Circulating Endothelial Progenitors in Patients With Critical Limb Ischemia ― The SCELTA Trial ―

Cited by 30 publications

References 43 publications

Impact of Therapeutic Angiogenesis Using Autologous Bone Marrow-Derived Mononuclear Cells Implantation in Critical Limb Ischemia With Scleroderma ― Subanalysis of the Long-Term Clinical Outcomes Survey ―

Impact of Therapeutic Angiogenesis Using Autologous Bone Marrow-Derived Mononuclear Cells Implantation in Critical Limb Ischemia With Scleroderma ― Subanalysis of the Long-Term Clinical Outcomes Survey ―

Autologous Peripheral Blood-derived Stem Cells Transplantation for Treatment of no-option Angiitis-induced Critical Limb Ischemia: 10-year Management Experience

The use of Peripheral Blood-Mononuclear Cells in Scleroderma patients: an observational preliminary study

Contact Info

Product

Resources

About

Therapeutic Efficacy of Autologous Non-Mobilized Enriched Circulating Endothelial Progenitors in Patients With Critical Limb Ischemia　― The SCELTA Trial ―

Impact of Therapeutic Angiogenesis Using Autologous Bone Marrow-Derived Mononuclear Cells Implantation in Critical Limb Ischemia With Scleroderma　― Subanalysis of the Long-Term Clinical Outcomes Survey ―

Impact of Therapeutic Angiogenesis Using Autologous Bone Marrow-Derived Mononuclear Cells Implantation in Critical Limb Ischemia With Scleroderma　― Subanalysis of the Long-Term Clinical Outcomes Survey ―