Autologous adipose tissue-derived stem cells treatment demonstrated favorable and sustainable therapeutic effect for Crohn's fistula

Abstract

Fistula is a representative devastating complication in Crohn's patients due to refractory to conventional therapy and high recurrence. In our phase I clinical trial, adipose tissue-derived stem cells (ASCs) demonstrated their safety and therapeutic potential for healing fistulae associated with Crohn's disease. This study was carried out to evaluate the efficacy and safety of ASCs in patients with Crohn's fistulae. In this phase II study, forty-three patients were treated with ASCs. The amount of ASCs was proportioned to fistula size and fistula tract was filled with ASCs in combination with fibrin glue after intralesional injection of ASCs. Patients without complete closure of fistula at 8 weeks received a second injection of ASCs containing 1.5 times more cells than the first injection. Fistula healing at week 8 after final dose injection and its sustainability for 1-year were evaluated. Healing was defined as a complete closure of external opening without any sign of drainage and inflammation. A modified per-protocol analysis showed that complete fistula healing was observed in 27/33 patients (82%) by 8 weeks after ASC injection. Of 27 patients with fistula healing, 26 patients completed additional observation study for 1-year and 23 patients (88%) sustained complete closure. There were no adverse events related to ASC administration. ASC treatment for patients with Crohn's fistulae was well tolerated, with a favorable therapeutic outcome. Furthermore, complete closure was well sustained. These results strongly suggest that autologous ASC could be a novel treatment option for the Crohn's fistula with high-risk of recurrence. STEM

Editorial: 2013—A Year of Clinical Success and Great Scientific Innovation in the Stem Cell Field

“…During the past year, STEM CELLS has been proud to publish exciting clinical advances in treating steroid-refractory Graft versus Host disease [1], Cerebral Palsy [2], Crohn's fistula [3], and treating alveolar bone defects with an injectable tissue engineered stem cell product, avoiding the donor site morbidity associated with bone autograft [4].…”

Systematic review of surgical interventions for Crohn's anal fistula

“…A summary of study characteristics is shown in Table  1, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75.…”

“…Six studies reported the outcome of stem cell therapy; five open label/phase I or II trials59 60, 63 65, 66, with longer‐term follow‐up61 of the cohort initially reported by Cho et al 60. in 2013.…”

“…Symptoms associated with disease flare, such as abdominal pain and diarrhoea, were reported in up to 60 per cent66 and 7 per cent61 respectively. Local complications included anal pain in 19 per cent66, anal inflammation in 7 per cent61, perianal swelling in 29 per cent59 and perianal abscess in 17–19 per cent59 66 of patients.…”

“…Local complications included anal pain in 19 per cent66, anal inflammation in 7 per cent61, perianal swelling in 29 per cent59 and perianal abscess in 17–19 per cent59 66 of patients.…”