Allogeneic adipose‐derived stem cells for the treatment of perianal fistula in Crohn's disease: a pilot clinical trial

Park, Kyu Joo; Ryoo, Sungwoo; Kim, Sang Woo; Kim, Tae Il; Baik, Seung Hyuk; Kim, Hyo Jong; Lee, Kil Yeon; Kim, Mihyung

doi:10.1111/codi.13223

Cited by 57 publications

(42 citation statements)

References 35 publications

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“…Two case series evaluated the possibility of immune reaction by measuring the ratio of CD4/CD8. In the study by Park et al, it was shown that the ratio of CD4/CD8 did not change . In the study by Lee et al, they found no immunological rejection responses in any of the subjects, based on the ratio of CD4‐positive to CD8‐positive T cells .…”

Section: Resultsmentioning

confidence: 94%

“…Almost all organ system have been implicated in adipose‐derived cell therapy. The indication for treatment in the included studies was (in order count) soft tissue , gastrointestinal , musculoskeletal , rheumatological , ulcer/ischemic limb , urogenital , cardiac , neurological , immunological , pulmonary , and ophthalmological (Fig. A).…”

Section: Resultsmentioning

confidence: 99%

“…Almost all organ system have been implicated in adipose-derived cell therapy. The indication for treatment in the included studies was (in order count) soft tissue www.StemCellsTM.com [18][19][20][21][22][23][24][25][26][27][28][29][30][31][32][33][34][35], gastrointestinal [8,[36][37][38][39][40][41][42][43][44][45][46][47][48], musculoskeletal [49][50][51][52][53][54][55][56][57][58], rheumatological [59][60][61][62][63], ulcer/ischemic limb [64][65][66][67], urogen...…”

Section: Description Of Included Studiesmentioning

confidence: 99%

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Concise Review: A Safety Assessment of Adipose-Derived Cell Therapy in Clinical Trials: A Systematic Review of Reported Adverse Events

Toyserkani

Jørgensen

Tabatabaeifar

et al. 2017

Stem Cells Translational Medicine

109

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The popularity of adipose‐derived cell therapy has increased over the last decade, and the number of studies published annually is growing. However, concerns regarding safety in the setting of previous malignancy or the use of allogeneic cells have been raised. We therefore aimed to systematically review all clinical studies using adipose‐derived cell therapy to identify reported adverse events with a special focus on risk of thromboembolic, immunological, and oncological safety concerns. Our systematic search resulted in 70 included studies involving more than 1,400 patients that were treated with adipose‐derived cell therapy. Safety assessment method was not described in 32 of the included studies. For studies involving systemic or cardiac administration, one case of pulmonary thromboembolism and cases of both myocardial and cerebral infarctions were described. In the setting of allogeneic cell therapy studies, where the production of specific antibodies toward donor cells was examined, it was noted that 19%–34% of patients develop antibodies, but the consequence of this is unknown. With regard to oncological safety, only one case of breast cancer recurrence was identified out of 121 patients. Adipose‐derived cell therapy has so far shown a favorable safety profile, but safety assessment description has, in general, been of poor quality, and only adverse events that are looked for will be found. We encourage future studies to maintain a strong focus on the safety profile of cell therapy, so its safeness can be confirmed. stem cells translational medicine 2017;6:1786–1794

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Section: Resultsmentioning

confidence: 94%

Section: Resultsmentioning

confidence: 99%

Section: Description Of Included Studiesmentioning

confidence: 99%

See 1 more Smart Citation

Concise Review: A Safety Assessment of Adipose-Derived Cell Therapy in Clinical Trials: A Systematic Review of Reported Adverse Events

Toyserkani

Jørgensen

Tabatabaeifar

et al. 2017

Stem Cells Translational Medicine

109

View full text Add to dashboard Cite

show abstract

“…In this patient population, ASC fistula injections increased the rate of fistula closure as assessed clinically and by MRI and even reduced the median time to clinical remission in one placebo‐controlled study (Fig. E) . In most of these studies, at least 50% of patients treated with ASC had complete closure of the treated fistula at the final time point of 240 days.…”

Section: Resultsmentioning

confidence: 88%

“…In 6 studies of 198 patients total, a variety of adverse events were reported including postoperative anal pain, abdominal pain, new fistulas, seton placement, fistula discharge, new abscesses, increases in C reactive protein, musculoskeletal and connective tissue disorders, eczema, exacerbation of disease, anal inflammation, infections, diarrhea, fever, anxiety, psychiatric disorders, and nasopharyngitis . No adverse events were related to the ASC in four studies . Anal abscess was most commonly listed as a treatment‐related adverse event .…”

Section: Resultsmentioning

confidence: 99%

Concise Review: Using Fat to Fight Disease: A Systematic Review of Nonhomologous Adipose-Derived Stromal/Stem Cell Therapies

et al. 2018

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The objective of this Review is to describe the safety and efficacy of adipose stem/stromal cells (ASC) and stromal vascular fraction (SVF) in treating common diseases and the next steps in research that must occur prior to clinical use. Pubmed, Ovid Medline, Embase, Web of Science, and the Cochrane Library were searched for articles about use of SVF or ASC for disease therapy published between 2012 and 2017. One meta-analysis, 2 randomized controlled trials, and 16 case series were included, representing 844 human patients. Sixty-nine studies were performed in preclinical models of disease. ASCs improved symptoms, fistula healing, remission, and recurrence rates in severe cases of inflammatory bowel disease. In osteoarthritis, ASC and SVF improved symptom-related, functional, radiographic, and histological scores. ASC and SVF were also shown to improve clinical outcomes in ischemic stroke, multiple sclerosis, myocardial ischemia, chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, chronic liver failure, glioblastoma, acute kidney injury, and chronic skin wounds. These effects were primarily paracrine in nature and mediated through reduction of inflammation and promotion of tissue repair. In the majority of human studies, autologous ASC and SVF from liposuction procedures were used, minimizing the risk to recipients. Very few serious, treatment-related adverse events were reported. The main adverse event was postprocedural pain. SVF and ASC are promising therapies for a variety of human diseases, particularly for patients with severe cases refractory to current medical treatments. Further randomized controlled trials must be performed to elaborate potential safety and efficacy prior to clinical use. Stem Cells 2018;36:1311-1328.

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Systematic review with meta‐analysis: Safety and efficacy of local injections of mesenchymal stem cells in perianal fistulas

et al. 2019

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Perianal fistulas in Crohn's disease (CD) represent a highly debilitating and difficult‐to‐treat condition. Given emerging supportive evidence, we conducted a systematic review and meta‐analysis of all trials/observational studies to establish the safety and efficacy of local injections of mesenchymal stem cells (MSCs). The PRISMA‐P statement was applied for planning and reporting, and MEDLINE, EMBASE, Web of Science, Cochrane, CINAHL, ClinicalTrials.gov database, and ECCO 2017 proceedings were searched for published observational studies and one‐arm and randomized clinical trials (RCTs). Safety was assessed in terms of acute local/systemic events, long‐term events, and relatedness with MSC treatment. Efficacy was evaluated in terms of external and/or radiological closure of fistula tracks. After a review of 211 citations, 23 studies, including 696 participants, were evaluated. Four were RCTs with a total of 483 patients. Overall, fistula closure occurred in 80% of MSC‐treated patients. In RCTs, this rate was 64% in the MSC arm and 37% in the control arm (relative risk (RR) = 1.54). Radiological response occurred in 83% of MSC‐treated patients. Treatment‐related adverse events occurred in 1% of MSC‐treated patients, with severe treatment‐related adverse events reaching 0% over a median follow‐up of 6 months. In RCTs, treatment‐related adverse events occurred in 13% in the MSC arm and 24% in the control arm (RR = 0.65). The relapse rate was 0. These results suggest that a local MSC injection is safe and efficacious. Further clinical trials with standardized end‐points are required to ensure the timely implementation of this new therapy in the management of perianal CD.

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Allogeneic adipose‐derived stem cells for the treatment of perianal fistula in Crohn's disease: a pilot clinical trial

Abstract: These data suggest that allogeneic adipose-derived stem cells may be a feasible treatment option for perianal fistula in Crohn's disease.

Cited by 57 publications

References 35 publications

Concise Review: A Safety Assessment of Adipose-Derived Cell Therapy in Clinical Trials: A Systematic Review of Reported Adverse Events

Concise Review: A Safety Assessment of Adipose-Derived Cell Therapy in Clinical Trials: A Systematic Review of Reported Adverse Events

Concise Review: Using Fat to Fight Disease: A Systematic Review of Nonhomologous Adipose-Derived Stromal/Stem Cell Therapies

Systematic review with meta‐analysis: Safety and efficacy of local injections of mesenchymal stem cells in perianal fistulas

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