NCT02384499

Brief Summary

  • Purpose: The investigators aimed to investigate the safety and efficacy in the treatment of fecal incontinence by injection of ALLO-ASC into the anal sphincter.
  • Method
  • Safety test of allogenic ASCs injection
  • Efficacy test of allogenic ASCs injection

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2014

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 10, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
Last Updated

August 13, 2018

Status Verified

August 1, 2018

Enrollment Period

2.6 years

First QC Date

February 24, 2015

Last Update Submit

August 10, 2018

Conditions

Fecal Incontinence

Outcome Measures

Primary Outcomes (1)

  • Clinically measured abnormality of laboratory tests and adverse events

    The investigators will assess the safety of allogenic-adipose-derived mesenchymal stem cell (ALLO-ASC) injection to the anal sphincter among the three experimental groups (group 1: 3x107 cells/ml; group 2: 6x107 cells/ml; group 3: 9x107 cells/ml)).

    one year (12 months)

Secondary Outcomes (1)

  • Satisfaction as measured by Wexner Score

    one year (12 months)

Study Arms (2)

ALLO-ASC group

EXPERIMENTAL

Allogenic-adipose-derived mesenchymal stem cell (ALLO-ASC) with fibrin glue injection to the anal sphincter

Biological: ALLO-ASC injection

Normal saline group

PLACEBO COMPARATOR

0.9% normal saline with fibrin glue injection to the anal sphincter

Drug: Placebo

Interventions

ALLO-ASC injectionBIOLOGICAL

Allogenic-adipose-derived mesenchymal stem cells (ALLO-ASC) injection to the anal sphincter of patients with fecal incontinence

Also known as: ALLO-ASC
ALLO-ASC group
PlaceboDRUG

0.9% normal saline with fibrin glue injection to the anal sphincter of patients with fecal incontinence

Also known as: Normal saline with fibrin glue injection
Normal saline group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 19 years old
  • Patients who received either medical therapy or biofeedback for fecal incontinence for more than 2 months with Wexner score ≥ 8
  • Transanal ultrasonography: presents a continuous fashion of anal sphincter
  • Anal manometery: decreased anal pressures than normal level
  • Negative for urine β-hCG in the screening test
  • An informed consent form has been signed by the patient

You may not qualify if:

  • Participation in another clinical trial within 30 days
  • History of anorectal surgery within the previous 6 months
  • History of malignant tumor surgery within the previous 5 years (except for carcinoma in situ)
  • Patients requiring anorectal surgical treatments
  • History of artificial sphincter surgery
  • History of vaginal delivery within 6 months
  • Medical history of variant Creutzfeld-Jakobs disease or related diseases
  • Allergy to bovine-derived materials, fibrin glue or anesthestics
  • Autoimmune disease
  • Active tuberculosis
  • Pregnant or breastfeeding women
  • Unwillingness to use contraceptive methods
  • Patients with inflammatory bowel disease
  • Alcohol or drug-abuse
  • Use of cytotoxic agents within 30 days
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Section of Colon and Rectal Surger, Department of Surgery, Yonsei University College of Medicine

Seoul, 135-720, South Korea

Location

Related Publications (7)

  • White AB, Keller PW, Acevedo JF, Word RA, Wai CY. Effect of myogenic stem cells on contractile properties of the repaired and unrepaired transected external anal sphincter in an animal model. Obstet Gynecol. 2010 Apr;115(4):815-823. doi: 10.1097/AOG.0b013e3181d56cc5.

    PMID: 20308844BACKGROUND

  • Parmar N, Kumar L, Emmanuel A, Day RM. Prospective regenerative medicine therapies for obstetric trauma-induced fecal incontinence. Regen Med. 2014;9(6):831-40. doi: 10.2217/rme.14.56.

    PMID: 25431918BACKGROUND

  • Kang SB, Lee HN, Lee JY, Park JS, Lee HS, Lee JY. Sphincter contractility after muscle-derived stem cells autograft into the cryoinjured anal sphincters of rats. Dis Colon Rectum. 2008 Sep;51(9):1367-73. doi: 10.1007/s10350-008-9360-y. Epub 2008 Jun 7.

    PMID: 18536965BACKGROUND

  • Lorenzi B, Pessina F, Lorenzoni P, Urbani S, Vernillo R, Sgaragli G, Gerli R, Mazzanti B, Bosi A, Saccardi R, Lorenzi M. Treatment of experimental injury of anal sphincters with primary surgical repair and injection of bone marrow-derived mesenchymal stem cells. Dis Colon Rectum. 2008 Apr;51(4):411-20. doi: 10.1007/s10350-007-9153-8. Epub 2008 Jan 26.

    PMID: 18224375BACKGROUND

  • Garcia-Olmo D, Herreros D, Pascual I, Pascual JA, Del-Valle E, Zorrilla J, De-La-Quintana P, Garcia-Arranz M, Pascual M. Expanded adipose-derived stem cells for the treatment of complex perianal fistula: a phase II clinical trial. Dis Colon Rectum. 2009 Jan;52(1):79-86. doi: 10.1007/DCR.0b013e3181973487.

    PMID: 19273960BACKGROUND

  • Rockwood TH, Church JM, Fleshman JW, Kane RL, Mavrantonis C, Thorson AG, Wexner SD, Bliss D, Lowry AC. Fecal Incontinence Quality of Life Scale: quality of life instrument for patients with fecal incontinence. Dis Colon Rectum. 2000 Jan;43(1):9-16; discussion 16-7. doi: 10.1007/BF02237236.

    PMID: 10813117BACKGROUND

  • Park EJ, Kang J, Baik SH. Treatment of faecal incontinence using allogeneic-adipose-derived mesenchymal stem cells: a study protocol for a pilot randomised controlled trial. BMJ Open. 2016 Feb 17;6(2):e010450. doi: 10.1136/bmjopen-2015-010450.

    PMID: 26888731DERIVED

MeSH Terms

Conditions

Fecal Incontinence

Interventions

Saline SolutionFibrin Tissue Adhesive

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsFibrinBlood ProteinsProteinsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2015

First Posted

March 10, 2015

Study Start

December 1, 2014

Primary Completion

June 30, 2017

Study Completion

June 30, 2017

Last Updated

August 13, 2018

Record last verified: 2018-08

Locations

KR(1)