NCT03056664

Brief Summary

Here investigators will carry out this phase II clinical trial to explore a effective therapeutic regimen of MSC in the Crohn's perianal fistula.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
3

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2017

Typical duration for phase_2

Status
unknown

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

First Submitted

Initial submission to the registry

August 24, 2015

Completed
1.4 years until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 17, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

February 17, 2017

Status Verified

September 1, 2016

Enrollment Period

2.9 years

First QC Date

August 24, 2015

Last Update Submit

February 14, 2017

Conditions

Crohn's DiseaseFistula

Outcome Measures

Primary Outcomes (1)

  • Clinical response(fistula closure)

    Physical examination indicates fistula healing, or MRI examinations showed fistula healing more than 2cm

    12 weeks

Secondary Outcomes (2)

  • C-reactive protein (CRP)

    12 weeks

  • Clinical Response

    6 weeks after receiving treatment

Study Arms (3)

MSC-1

EXPERIMENTAL

Patient in this arm will receive routine surgery and local MSC injection of 3×10E6/kg

Procedure: Routine drainage surgeryBiological: MSC injection 01

MSC-2

EXPERIMENTAL

Patient in this arm will receive routine surgery and local MSC injection of 6×10E6/kg

Procedure: Routine drainage surgeryBiological: MSC injection 02

Ctrl

EXPERIMENTAL

Patient in this arm will receive routine surgery and local NS injection

Procedure: Routine drainage surgeryOther: placebo

Interventions

Routine drainage surgeryPROCEDURE
CtrlMSC-1MSC-2
MSC injection 01BIOLOGICAL

Local MSC injection in peri-anal with a dose of 3×10E6/kg

MSC-1
MSC injection 02BIOLOGICAL

Local MSC injection in peri-anal with a dose of 6×10E6/kg

MSC-2
placeboOTHER

NS injection instead of MSC

Ctrl

Eligibility Criteria

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

You may qualify if:

  • Age 18-65 years old, male or female;
  • refractory CD fistula, there are 1-2 and 1-3 in the mouth fistula;
  • Diagnostic CD at least three months;
  • CDAI \<250;
  • were receiving drug treatment (5-ASA and hormones\> 4 weeks, immunosuppressants and biological agents\> 8 weeks);
  • signed informed consent.

You may not qualify if:

  • with intestinal obstruction, stenosis, or perianal abscess;
  • pregnant or lactating women;
  • infection needs antibiotics persons;
  • rectovaginal fistula;
  • complex anal fistula more than two inside the mouth;
  • stenosis or perforation CD;
  • perianal infection;
  • could not do rectal or anal stenosis local injection therapy;
  • with acute enteritis;
  • , liver and kidney dysfunction;
  • a month have used other drugs are in clinical trials;
  • no conditions or unwilling to carry out MRI inspected;
  • who are adjusting therapy;
  • HIV patients;
  • The combined active hepatitis or tuberculosis; Occurred in 16) 6 months opportunistic infections, or severe infections occur within three months;
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Crohn DiseaseFistula

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2015

First Posted

February 17, 2017

Study Start

January 1, 2017

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

February 17, 2017

Record last verified: 2016-09