Stem Cells Treatment for Extremely Complex Fistulae (HULPCIR)

NCT01586715 | Unknown Phase 2

• 2 other identifiers: HULPCIR-2010-012010-024329-19
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the practicability of the autologous e-ASC (Autologous Stem Cells) for the treatment of extremely complex and treatment resistant perianal fistulae.

Conditions

Extremely Complex Perianal Fistulae

Keywords

Extremely complex perianal fistula; Adipose Derived Stem Cells

Outcome Measures

Primary Outcomes (1)

• Safety of treatment of extremely complex perianal fistulae. Percentage of treated extremely complex perianal fistulae and percentage of subjects with closed fistulae

  Safety by control the adverse effects associated with treatment Fistula close by 3D ultrasound

  16 weeks

Secondary Outcomes (2)

• Quality of life assessment using the SF-12 Questionnaire

  1, 4, 16,24 weeks

• Adverse events

  1, 4, 12, 24 weeks

Study Arms (1)

Autologous Stem Cells

EXPERIMENTAL

Drug: Adipose-derived stem cells without expanded

Interventions

Adipose-derived stem cells without expanded DRUG

Administration will be intralesional injection of cells suspension. They will be placed into fistula walls

Autologous Stem Cells

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• Extremely Complex perianal fistulae
• Men and women over 18 years old. Good general state of health according to the findings of the clinical history and the physical examination
• Previous failure in at least one closing fistula standard treatment

You may not qualify if:

• Presence of severe proctitis or dominant active luminal disease requiring immediate therapy
• Patients with an abscess unless a complete toilet of the area with drainage of the collections and the absence of abscess and other collections is confirmed prior to treatment start
• Patients with malignant tumor, except for basal cell or cutaneous squamous cell carcinoma, or patients with a prior history of malignant tumors, unless the neoplastic disease has been in remission for the previous 5 years
• Patients with cardiopulmonary disease which, in opinion of the investigator, in unstable or sufficiently serious to exclude the patient from the study.
• Patients with congenital or acquired immunodeficiencies. HIV, HBV, HCV or treponema infection, whether active or latent
• Patients who have suffering major surgery or severe trauma in the prior 6 months
• Pregnant or breastfeeding women
• Patients currently receiving, or having received within 1 month prior to enrollment into this clinical trial, any investigational drug

Sponsors & Collaborators

• Instituto de Investigación Hospital Universitario La Paz: lead

Study Sites (1)

Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

RECRUITING

Related Publications (24)

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  BACKGROUND

• Given FT Jr. Rectovaginal fistula. A review of 20 years' experience in a community hospital. Am J Obstet Gynecol. 1970 Sep 1;108(1):41-6. No abstract available.

  PMID: 4916866 BACKGROUND

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  BACKGROUND

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• Fry RD, Shemesh EI, Kodner IJ, Timmcke A. Techniques and results in the management of anal and perianal Crohn's disease. Surg Gynecol Obstet. 1989 Jan;168(1):42-8.

  PMID: 2909131 BACKGROUND

• Radcliffe AG, Ritchie JK, Hawley PR, Lennard-Jones JE, Northover JM. Anovaginal and rectovaginal fistulas in Crohn's disease. Dis Colon Rectum. 1988 Feb;31(2):94-9. doi: 10.1007/BF02562636.

  PMID: 3338350 BACKGROUND

• Tuxen PA, Castro AF. Rectovaginal fistula in Crohn's disease. Dis Colon Rectum. 1979 Jan-Feb;22(1):58-62. doi: 10.1007/BF02586761. No abstract available.

  PMID: 421652 BACKGROUND

• Hellers G, Bergstrand O, Ewerth S, Holmstrom B. Occurrence and outcome after primary treatment of anal fistulae in Crohn's disease. Gut. 1980 Jun;21(6):525-7. doi: 10.1136/gut.21.6.525.

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• Bandy LC, Addison A, Parker RT. Surgical management of rectovaginal fistulas in Crohn's disease. Am J Obstet Gynecol. 1983 Oct 15;147(4):359-63. doi: 10.1016/s0002-9378(16)32225-6.

  PMID: 6624806 BACKGROUND

• Bauer JJ, Sher ME, Jaffin H, Present D, Gelerent I. Transvaginal approach for repair of rectovaginal fistulae complicating Crohn's disease. Ann Surg. 1991 Feb;213(2):151-8. doi: 10.1097/00000658-199102000-00010.

  PMID: 1992942 BACKGROUND

• Tsang CB, Madoff RD, Wong WD, Rothenberger DA, Finne CO, Singer D, Lowry AC. Anal sphincter integrity and function influences outcome in rectovaginal fistula repair. Dis Colon Rectum. 1998 Sep;41(9):1141-6. doi: 10.1007/BF02239436.

  PMID: 9749498 BACKGROUND

• Andreani SM, Dang HH, Grondona P, Khan AZ, Edwards DP. Rectovaginal fistula in Crohn's disease. Dis Colon Rectum. 2007 Dec;50(12):2215-22. doi: 10.1007/s10350-007-9057-7. Epub 2007 Sep 11.

  PMID: 17846837 BACKGROUND

• García Olmo D, García-Verdugo JM, Alemany J, Gonzalez M, Gutierrez-Fuentes JA. CELL THERAPHY . Ed. Mac Graw Hill. Madrid 2007

  BACKGROUND

• Aggarwal S, Pittenger MF. Human mesenchymal stem cells modulate allogeneic immune cell responses. Blood. 2005 Feb 15;105(4):1815-22. doi: 10.1182/blood-2004-04-1559. Epub 2004 Oct 19.

  PMID: 15494428 BACKGROUND

• Puissant B, Barreau C, Bourin P, Clavel C, Corre J, Bousquet C, Taureau C, Cousin B, Abbal M, Laharrague P, Penicaud L, Casteilla L, Blancher A. Immunomodulatory effect of human adipose tissue-derived adult stem cells: comparison with bone marrow mesenchymal stem cells. Br J Haematol. 2005 Apr;129(1):118-29. doi: 10.1111/j.1365-2141.2005.05409.x.

  PMID: 15801964 BACKGROUND

• Tse WT, Pendleton JD, Beyer WM, Egalka MC, Guinan EC. Suppression of allogeneic T-cell proliferation by human marrow stromal cells: implications in transplantation. Transplantation. 2003 Feb 15;75(3):389-97. doi: 10.1097/01.TP.0000045055.63901.A9.

  PMID: 12589164 BACKGROUND

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• Garcia-Olmo D, Garcia-Arranz M, Garcia LG, Cuellar ES, Blanco IF, Prianes LA, Montes JA, Pinto FL, Marcos DH, Garcia-Sancho L. Autologous stem cell transplantation for treatment of rectovaginal fistula in perianal Crohn's disease: a new cell-based therapy. Int J Colorectal Dis. 2003 Sep;18(5):451-4. doi: 10.1007/s00384-003-0490-3. Epub 2003 May 20.

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  PMID: 19273960 BACKGROUND

Study Officials

• Damián García Olmo, Prof MD

  General Surgery Department (Hospital Universitario La Paz) and Cell Therapy laboratory

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Damián García Olmo, Prof MD

CONTACT

0034 912071022; damian.garcia@uam.es

Mariano A García Arranz, PhD

CONTACT

0034 912071022; mgarciaa.hulp@salud.madrid.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2012
• First Posted: April 27, 2012
• Study Start: March 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 27, 2012

Record last verified: 2012-04

Locations

ES (1)