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Seoul, South Korea

Park K.J.,Seoul National University | Ryoo S.-B.,Seoul National University | Kim J.S.,Seoul National University | Kim T.I.,Yonsei University | And 5 more authors.
Colorectal Disease | Year: 2016

Aim: Many perianal fistulae in Crohn's disease do not respond to conventional surgical and medical management and recurrence rates are high. The study evaluated the safety and feasibility of allogeneic adipose-derived stem cells for the treatment of perianal fistula in Crohn's disease. Method: A multicentre, open-label, dose escalation pilot study was performed. The first three patients (group 1) were administered 1 × 107 cells/ml based on the size of the fistula tract. Four weeks later, after which time this dose had been confirmed to be safe, the next three patients (group 2) were administered 3 × 107 cells/ml. The end-point was complete closure at 8 weeks after the injection. Patients who attended for the 8 week assessment were followed for an additional 6 months. Results: There were no adverse events of Grade 3 or 4 severity and no adverse events related to the treatment with allogeneic adipose-derived stem cells. Two patients in group 1 achieved complete closure of the fistula at month 4 and month 6, and one patient in group 2 achieved complete closure at 8 weeks. The closure was sustained up to month 8 in all three of those patients. Conclusion: These data suggest that allogeneic adipose-derived stem cells may be a feasible treatment option for perianal fistula in Crohn's disease. © 2016 The Association of Coloproctology of Great Britain and Ireland.

Cho Y.B.,Sungkyunkwan University | Lee W.Y.,Sungkyunkwan University | Park K.J.,Seoul National University | Kim M.,Anterogen Co. | And 2 more authors.
Cell Transplantation | Year: 2013

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 ́ 107 cells/ml. After 4 weeks, this dose was deemed safe, and so an additional four patients (group 2) were given 2 ́ 107 cells/ml. Four weeks later, after which this second dose was deemed safe, a third and final group of three patients were given 4 ́ 107 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 ́ 107 ASCs/ml, showed complete healing at week 8 after injection. Of the three patients enrolled in group 3, treated with 4 ́ 107 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. © 2013 Cognizant Comm. Corp.

The present invention relates to a method for producing clinically effective quantities of human adipose tissue-derived stromal cells for treating fistulas and a composition made with the same. The method of the present invention can efficiently produce clinically effective number of adipose tissue-derived stromal cells within a short period by improving conventional standard culturing methods. The adipose stem cells composition containing the adipose tissue-derived stromal cells obtained by the method of the present invention exhibit superior multipotency and immunomodulatory activity over those of a cell composition produced by conventional methods, and thus is more suitable for treating fistulas. The cell composition of the present invention has excellent clinical usages especially since immune response is suppressed in allogenic adipose-derived stem cells.

Cho Y.B.,Sungkyunkwan University | Park K.J.,Seoul National University | Yoon S.N.,University of Ulsan | Song K.H.,Daehang Hospital | And 5 more authors.
Stem Cells Translational Medicine | Year: 2015

A previous phase II clinical trial of adipose-derived stem cell (ASC) therapy for fistulae associated with Crohn’s disease, a devastating condition with a high recurrence rate, demonstrated safety and therapeutic potential with a 1-year sustained response. In the present study, 41 of the 43 phase II trial patients were followed for an additional year, regardless of response in the initial year. At 24 months, complete healing was observed in 21 of 26 patients(80.8%) in modified per protocol analysis and 27 of 36 patients (75.0%) in modified intention-to-treat analysis. No adverse events related to ASC administration were observed. Furthermore, complete closure after initial treatment was well-sustained. These results strongly suggest that autologous ASCs may be a novel treatment option for Crohn’s fis-tulae. © Alpha Med Press 2015.

Kim I.,Ewha Womans University | Kim I.,Anterogen Co. | Bang S.I.,Sungkyunkwan University | Lee S.K.,Anterogen Co. | And 3 more authors.
Stem Cells Translational Medicine | Year: 2014

Werecently reported that autologous adipogenic differentiated adipose-derived stem cells (ASCs) can potentially be used as an effective and safe therapy for soft-tissue regeneration. In the present study, we investigated whether adipogenic differentiated ASCs can be used for allogenic applications to enlarge their therapeutic use. The allogenic immune response of adipogenic differentiated ASCs was investigated by flow cytometry and mixed lymphocyte culture. To determine whether adipogenic differentiated ASCs can form new adipose tissue without immune rejection, these cells were implanted subcutaneously into allo-or xenogenic recipient mice. In addition, the safety of the allogenic implantation of adipogenic differentiated ASCs was explored in a phase I clinical study. Adipogenic differentiated ASCs do not express major histocompatibility complex (MHC) class II molecules and costimulatory molecules, and the expression levels of MHC class I decreased after differentiation. In addition, these cells do not elicit an immune response againstMHC-mismatched allogenic lymphocytes and formed new adipose tissue without immune rejection in the subcutaneous region ofMHC-mismatched mice.Moreover, these cells did not induce clinically significant local and systemic immune responses or adverse events in the subcutaneous region of donor-independent healthy subjects. These results suggest that adipogenic differentiated ASCs can beused as a “universal donor” for soft-tissue engineering in MHC-mismatched recipients. © AlphaMed Press.

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