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  • Chen, Bin  (8)
  • Gu, Shiyang  (8)
  • 1
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    Return to work after cell transplantation in patients with angiitis-induced critical limb ischaemia and factors related: a single-centre retrospective cohort study
    Springer Science and Business Media LLC ; 2022
    In:  Stem Cell Research & Therapy Vol. 13, No. 1 ( 2022-12)
    Details
    In: Stem Cell Research & Therapy, Springer Science and Business Media LLC, Vol. 13, No. 1 ( 2022-12)
    Abstract: Angiitis-induced critical limb ischaemia (AICLI) patients, who are usually young and have a high amputation rate, always lose their ability to return to the labour force. Return to work (RTW) not only indicates patients’ physical health, showing that they could undertake the work, but also demonstrates their psychological well-being. While cell transplantation showed satisfactory efficacy in limb salvage, few studies of AICLI patients’ RTW after transplantation have been reported. Methods From May 2009 to May 2021, AICLI patients who underwent cell transplantation and completed no less than 12 months of follow-up were retrospectively enrolled. The primary endpoint was RTW. Patient demographics and characteristics of the ischaemic limbs were reviewed to analyse independent risk factors for RTW. Results A total of 171 AICLI patients (170 males) were enrolled with a mean age of 41.9 ± 9.6 years (range: 20–57 years). The 12-month and 24-month RTW cumulative rates were 69.4% (95% confidence interval [CI] 61.6–75.6%) and 70.1% (95% CI 62.3–76.2%), respectively. Age  〈  40 years (odds ratio [OR] 2.659, 95% CI 1.138–6.719) and preoperative occupation as a mental worker (OR 8.930, 95% CI 2.665–42.847) were identified as independent protective factors for RTW. Perioperative limb infection with ulcer or gangrene (OR 0.250, 95% CI 0.075–0.779) was identified as an independent risk factor. Conclusion AICLI patients who underwent cell transplantation usually had a satisfactory midterm RTW cumulative rate. AICLI patients  〈  40 years old with preoperative occupation as mental workers were more likely to return to work. Prevention of limb infection during the perioperative period is of great significance to RTW.
    Type of Medium: Online Resource
    ISSN: 1757-6512
    URL: Article
    DOI: 10.1186/s13287-022-02807-1
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2022
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  • 2
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    Long-Term Outcomes of Peripheral Blood Mononuclear Cells in the Treatment of Angiitis-Induced No-Option Critical Limb-Threatening Ischemia
    Elsevier BV ; 2021
    In:  SSRN Electronic Journal
    Details
    In: SSRN Electronic Journal, Elsevier BV
    Type of Medium: Online Resource
    ISSN: 1556-5068
    URL: Article
    DOI: 10.2139/ssrn.3896560
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2021
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  • 3
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    Autologous peripheral blood-derived stem cells transplantation for treatment of no-option angiitis-induced critical limb ischemia: 10-year management experience
    Springer Science and Business Media LLC ; 2020
    In:  Stem Cell Research & Therapy Vol. 11, No. 1 ( 2020-12)
    Details
    In: Stem Cell Research & Therapy, Springer Science and Business Media LLC, Vol. 11, No. 1 ( 2020-12)
    Abstract: 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.
    Type of Medium: Online Resource
    ISSN: 1757-6512
    URL: Article
    DOI: 10.1186/s13287-020-01981-4
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2020
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  • 4
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    Three-year outcomes of peripheral blood mononuclear cells vs purified CD34+ cells in the treatment of angiitis-induced no-option critical limb ischemia and a cost-effectiveness assessment: A randomized single-blinded noninferiority trial
    Oxford University Press (OUP) ; 2021
    In:  Stem Cells Translational Medicine Vol. 10, No. 5 ( 2021-05-01), p. 647-659
    Details
    In: Stem Cells Translational Medicine, Oxford University Press (OUP), Vol. 10, No. 5 ( 2021-05-01), p. 647-659
    Abstract: For patients with angiitis-induced critical limb ischemia (AICLI), cell transplantation, such as purified CD34+ cells (PCCs) and peripheral blood mononuclear cells (PBMNCs), is gradually being used as a promising treatment. This was the first randomized single-blinded noninferiority trial (number: NCT 02089828) specifically designed to evaluate the therapeutic efficacies of the transplantation of PCCs vs those of PBMNCs for the treatment of AICLI. We aimed to compare the mid-term safety and efficacy between the two groups and determine their respective advantages. From April 2014 to September 2019, 50 patients with AICLI were equally allocated to the two groups, except for 1 lost patient, 1 amputee, and 1 patient who died of heart disease. The other 47 patients completed the 36-month follow-up. The endpoints were as follows: major amputation-free survival and total amputation-free survival at 6 months, which were 96.0% and 84.0% in the PBMNCs group and 96.0% and 72.0% in the PCCs group, respectively. These rates remained stable at 12, 24, and 36 months. The PCCs group had a significant higher probability of rest pain relief than the PBMNCs group, whereas earlier significant improvements in the Rutherford classification were observed in the PBMNCs group. Accordingly, PCCs would be preferred for patients with significant pain, whereas PBMNCs may be a good option for patients with two or more critically ischemic limbs. Concerning cost-effectiveness, PCCs are not more cost-effective than PBMNCs. These outcomes require verification from long-term trials involving larger numbers of patients.
    Type of Medium: Online Resource
    ISSN: 2157-6564 , 2157-6580
    URL: Article
    DOI: 10.1002/sctm.20-0033
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2021
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  • 5
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    Long-Term Outcomes of Peripheral Blood Mononuclear Cells in the Treatment of Angiitis-Induced No-Option Critical Limb-Threatening Ischemia
    Frontiers Media SA ; 2021
    In:  Frontiers in Cardiovascular Medicine Vol. 8 ( 2021-12-6)
    Details
    In: Frontiers in Cardiovascular Medicine, Frontiers Media SA, Vol. 8 ( 2021-12-6)
    Abstract: Background: Peripheral blood mononuclear cells (PBMNCs) showed encouraging short outcomes in the treatment of angiitis-induced no-option critical limb-threatening ischemia (AICLTI) in the pilot study. This study aimed to demonstrate the long-term outcomes of this treatment. Methods: From May 2014 to December 2018, patients diagnosed with AICLTI and treated by autotransplantation of PBMNCs in our center were enrolled and analyzed. The primary endpoint was major amputation-free survival (MAFS), the secondary endpoints included peak pain-free walking time (PPFWT), Wong-Baker FACES pain rating scale score (WFPRSS), labor recovery, ankle-brachial index (ABI), transcutaneous partial oxygen pressure (TcpO2), and SF-36v2 scores. Results: A total of 58 patients were enrolled. During a minimal follow-up of 36 months, the MAFS was 93.1% and the labor competence restored rate was 62.1%. The WFPRSS was decreased from 8.7 ± 1.6 to 1.6 ± 3.2, and PPFWT was significantly improved from 2.9 ± 4.2 min to 16.6 ± 6.9 min. The quality of life was also significantly improved at each follow-up point. Perfusion evaluating parameters, such as ABI and TcPO2, were also significantly improved. No critical adverse event was observed during the treatment and follow-up period. Conclusions: The treatment of AICLTI by autotransplantation of PBMNCs demonstrated encouraging long-term results. It could not only restore labor competence, improve the quality of life, but also significantly reduce the major amputation rate.
    Type of Medium: Online Resource
    ISSN: 2297-055X
    URL: Article
    DOI: 10.3389/fcvm.2021.769472
    Language: Unknown
    Publisher: Frontiers Media SA
    Publication Date: 2021
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  • 6
    Online Resource
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    Return to Work After Cell Transplantation in Patients With Angiitis-Induced Critical Limb Ischemia and Factors Related
    Elsevier BV ; 2021
    In:  SSRN Electronic Journal
    Details
    In: SSRN Electronic Journal, Elsevier BV
    Type of Medium: Online Resource
    ISSN: 1556-5068
    URL: Article
    DOI: 10.2139/ssrn.3907835
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2021
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  • 7
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    The peripheral blood mononuclear cells versus purified CD34+ cells transplantation in patients with angiitis-induced critical limb ischemia trial: 5-year outcomes and return to work analysis—a randomized single-blinded non-inferiority trial
    Springer Science and Business Media LLC ; 2022
    In:  Stem Cell Research & Therapy Vol. 13, No. 1 ( 2022-12)
    Details
    In: Stem Cell Research & Therapy, Springer Science and Business Media LLC, Vol. 13, No. 1 ( 2022-12)
    Abstract: Patients with AICLI constitute a considerable proportion of NO-CLI patients and cannot be treated with surgical or endovascular treatment. Although cell therapy has shown satisfactory results in treating AICLI, research comparing the efficacy of treatment with the 2 kinds of cell products is rare. The aim of this study was to report the 5-year outcomes of a randomized single-blinded noninferiority trial (Number: NCT 02089828) on peripheral blood mononuclear cells (PBMNCs) and purified CD34 + cells (PCCs) transplantation for treating angiitis-induced critical limb ischemia (AICLI). Methods A randomized single-blinded non-inferiority trial (Number: NCT 02089828) was performed. Fifty patients were randomized 1:1 to the PBMNCs and PCCs groups. Efficacy outcomes, safety outcomes and patients’ work conditions were analyzed. The primary efficacy outcomes included major amputation and total amputation over 60 months. Results During the 60-month follow-up, 1 patient was lost to follow-up, 1 died, and 2 underwent major amputation. The major amputation-free survival rate (MAFS) was 92.0% (95% confidence interval [CI] 82.0%-100.0%) in the PBMNCs group and 91.7% (95% CI 81.3%-100.0%) in the PCCs group ( P  = 0.980). Compared with the PCCs group, the PBMNCs group had a significantly higher 5-year new lesion-free survival rate (100.0% vs. 83.3% [95% CI 69.7–99.7%], P  = 0.039). All patients lost their ability to work before transplantation, and the 5-year cumulative return to work (RTW) rates were 88.0% in the PBMNCs group and 76.0% in the PCCs group ( P  = 0.085). Conclusion The long-term follow-up outcomes of this trial not only demonstrated similar efficacy and safety for the 2 types of autoimplants but also showed a satisfactory cumulative RTW rate in AICLI patients who underwent cell transplantation. Trial registration : ClinicalTrials.gov, number NCT 02089828. Registered 14 March 2014, https://clinicaltrials.gov/ct2/show/record/NCT02089828 .
    Type of Medium: Online Resource
    ISSN: 1757-6512
    URL: Article
    DOI: 10.1186/s13287-022-02804-4
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2022
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  • 8
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    Autologous Stem Cells Transplantation for No-Option Angiitis-Induced Critical Limb Ischemia: Recurrence and New Lesion
    Oxford University Press (OUP) ; 2022
    In:  Stem Cells Translational Medicine Vol. 11, No. 5 ( 2022-05-27), p. 504-512
    Details
    In: Stem Cells Translational Medicine, Oxford University Press (OUP), Vol. 11, No. 5 ( 2022-05-27), p. 504-512
    Abstract: Although satisfying outcomes have been demonstrated in terms of autologous stem cell transplantation in the treatment of angiitis-induced critical limb ischemia (AICLI), few studies have systematically reported the recurrence conditions. In the current study, we aimed to investigate recurrence conditions of a relatively large AICLI cohort in our center during a long-term follow-up period. From May 2009 to August 2020, 181 patients with AICLI received peripheral blood mononuclear cells (PBMNCs) or purified CD34+ cells (PCCs) transplantation. The main outcomes included recurrence and new lesions. Patient demographic data, ischemic limb characteristics, interventional characteristics, etc., were identified and analyzed. A logistic multivariable regression was performed to identify the independent risk factors for recurrence by a stepwise selection of variables. One hundred forty-eight patients were enrolled in this study. The mean follow-up period was 62.3 ± 37.4 months (range 12-144 months). The 5- and 10-year recurrence-free rates were 88.5% (95% confidence interval [CI] 3.1%-82.6%) and 71.7% (95% CI 7.6%-58.2%), respectively. The 5- and 10-year new lesion-free rates were 93.2% (95% CI 2.2%-89.0%) and 91.7% (95% CI 2.7%-86 .6%), respectively. The finding of multiple limbs involved (OR 1.322 95% CI 1.123-12.549, P = .036) and ischemia relief period ≥5 months (OR 3.367 95% CI 1.112-10.192, P = .032) were demonstrated to be independent risk factors for recurrence in patients with AICLI who underwent cell transplantation. For patients with AICLI who responded to cell transplantation, the durability of this therapy was satisfactory, with 5- and 10-year recurrence-free rates of 88.5% and 71.7%, respectively. Multiple limbs involved at admission and ischemia relief period ≥5 months were demonstrated to be independent risk factors for recurrence after transplantation.
    Type of Medium: Online Resource
    ISSN: 2157-6564 , 2157-6580
    URL: Article
    DOI: 10.1093/stcltm/szac017
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2022
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