NCT01314092

Brief Summary

Mesenchymal stem cells derived from adipose tissue are pluripotent to differentiate into myocytes, adipocytes or others. They have an immunosuppressive activity. Complex perianal fistula is difficult to cure and easy to relapse. Autologous adipose stem cells have shown efficacy and safety on Crohn's fistula in phase 1 study. Based on these results, the investigators would apply autologous adipose stem cells on complex perianal fistula to evaluate their efficacy and safety.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2011

Typical duration for phase_2

Geographic Reach
1 country

6 active sites

Status
terminated

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

January 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 14, 2011

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

November 23, 2016

Status Verified

March 1, 2011

Enrollment Period

3.7 years

First QC Date

March 8, 2011

Last Update Submit

November 21, 2016

Conditions

Complex Perianal Fistula

Keywords

crohn's diseasefistulacomplex

Outcome Measures

Primary Outcomes (1)

  • Number of patients with complete closure of fistula (week 8)

    Proportion of patients with completely closed fistula (week 8)

    8 weeks

Secondary Outcomes (4)

  • Grade of investigator's satisfaction

    8 weeks

  • Number of patients with closed fistula

    8 weeks

  • Photo of target fistula

    8 weeks

  • Number of patients with adverse events

    8 weeks

Study Arms (2)

Group 1

EXPERIMENTAL

Low dose group

Biological: Autologous cultured adipose derived stem cells(low dose group)

Group 2

EXPERIMENTAL

high dose group

Biological: Autologous cultured adipose derived stem cells(high dose group)

Interventions

Autologous cultured adipose derived stem cells(low dose group)BIOLOGICAL

low dose group: 1x10e7 cells/mL At 6 weeks after first stem cell injection, fistula closing was assessed. If it is not completely closed, second injection would be applied in 2 weeks. Additional dosage would be doubled to first dosage.

Also known as: mesenchymal stem cell, ANTG-ASC, adipose derived stem cell, Group1: low dose group
Group 1
Autologous cultured adipose derived stem cells(high dose group)BIOLOGICAL

high dose group: 2x10e7 cells/mL At 6 weeks after first stem cell injection, fistula closing was assessed. If it is not completely closed, second injection would be applied in 2 weeks. Additional dosage would be doubled to first dosage.

Also known as: mesenchymal stem cell, ANTG-ASC, adipose derived stem cell, Group2: high dose group
Group 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • a patient who has complex perianal fistula
  • a patient who is negative in pregnancy test
  • a patient who has submitted a written consent

You may not qualify if:

  • a patient who has participated in other clinical studies within 30 days before this clinical trial or has not passed 5 fold period of a half-life of other investigational drugs.
  • a patient who has a history of variant Creutzfeldt Jacobs disease or related diseases
  • a patient who is allergic to anesthetics, bovine derived proteins or a fibrin glue
  • a patient who has an autoimmune disease
  • a patient who has infectious diseases such as hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV)
  • a patient who has sepsis or active tuberculosis
  • a patient who is pregnant or breast feeding
  • a patient who has inflammatory Bowel disease
  • over 2cm in diameter of fistula

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Soon cheun Hyang university bucheon hospital

Bucheon-si, 420-767, South Korea

Location

Ewha womwn university mokdong hospital

Seoul, 158-710, South Korea

Location

DaeHang Hospital

Seoul, South Korea

Location

Samsung seoul Hospital

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Seoul Saint Mary's Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Crohn DiseaseFistula

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DemographyPopulation Characteristics

Study Officials

  • KJ Park, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

  • DS Kim

    Daehang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2011

First Posted

March 14, 2011

Study Start

January 1, 2011

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

November 23, 2016

Record last verified: 2011-03

Locations

KR(6)