No 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

Age, sex, and ultralow anterior resection were found to be risk factors for anastomotic leakage after rectal cancer surgery. In addition, leakage was associated with poor survival.

After ileal pouch-anal anastomosis patients with indeterminate colitis who did not develop Crohn's disease subsequently experienced long-term outcomes nearly identical to patients with chronic ulcerative colitis. Crohn's disease, whether it develops after surgery for chronic ulcerative colitis or indeterminate colitis, is associated with poor long-term outcomes.

Korean CD patients differed from Western patients in gender distribution, disease location, and perianal fistula occurrence. Korean CD patients may also have better clinical courses than Western patients, as indicated by the lower intestinal resection rate.

The present study was designed to evaluate the safety and potential of adipose tissue-derived stem cells (ASCs) for the treatment of Crohn's fistula. In this dose escalation study, patients were sequentially enrolled into three dosing groups with at least three patients per group. The first three patients (group 1) were given 1 ´ 10 7 cells/ml. After 4 weeks, this dose was deemed safe, and so an additional four patients (group 2) were given 2 ´ 10 7 cells/ml. Four weeks later, after which this second dose was deemed safe, a third and final group of three patients were given 4 ´ 10 7 cells/ml. Each patient was followed for a minimum of 8 weeks. Patients who showed complete healing at week 8 were followed up for an additional 6 months. Efficacy endpoint was complete healing at week 8 after injection, defined as complete closure of the fistula track and internal and external openings without drainage or signs of inflammation. There were no grade 3 or 4 severity adverse events, and there were no adverse events related to the study drug. Two patients in group 2, treated with 2 ´ 10 7 ASCs/ml, showed complete healing at week 8 after injection. Of the three patients enrolled in group 3, treated with 4 ´ 10 7 ASCs/ml, one showed complete healing. Outcome in another patient was assessed as partial healing due to incomplete closure of the external opening, although the inside of fistula track was filled considerably and there was no drainage. All three patients with complete healing at week 8 showed a sustained effect without recurrence 8 months after injection. In conclusion, this study demonstrates the tolerability, safety, and potential efficacy of ASCs for the treatment of Crohn's fistula and provides support for further clinical study.

Biofeedback therapy produced significant clinical benefits for patients with severe fecal incontinence and may be an effective treatment for patients with anterior resection syndrome after surgery for rectal cancer.

BACKGROUND: Although many trials have shown the efficacy of preoperative chemoradiotherapy (CRT) or postoperative CRT compared with surgery alone, the optimal sequence of radiotherapy and surgery is unclear. The authors reported the final results of this single institution prospective randomized phase 3 trial comparing preoperative CRT with postoperative CRT using capecitabine in survival, local control, sphincter preservation, and toxicity for the treatment of locally advanced rectal cancer. METHODS: Patients with locally advanced rectal cancer (cT3, potentially resectable cT4 or Nþ) were randomly assigned to receive preoperative or postoperative CRT. CRT consisted of 50 Gy/ 25 fractions and concurrent capecitabine (1,650 mg/m