NCT02532738

Brief Summary

The investigators' preliminary study indicates that MSC is effective therapy in treating IBD. But the standard treatment is still lacking and the effect is not stable in IBD patients. This study is to explore the efficacy and standard strategy when using MSC in refractory IBD.

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 2016

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 23, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 26, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

August 26, 2015

Status Verified

August 1, 2015

Enrollment Period

2.8 years

First QC Date

August 23, 2015

Last Update Submit

August 25, 2015

Conditions

Crohn's Disease

Keywords

efficacy of MSCrefractory

Outcome Measures

Primary Outcomes (1)

  • Clinical Response of CD patients 12 weeks after receiving treatment (Reduction of CDAI score at less 100)

    Reduction of CDAI score at less 100

    12 weeks after receiving treatment

Secondary Outcomes (1)

  • Clinical Response of CD patients 6 weeks after receiving treatment (CDAI score less than 150)

    6 weeks after receiving treatment

Study Arms (3)

MSC-1

EXPERIMENTAL

Patients in this arms receive routine treatment with 3×10E6/kg of MSC

Drug: Routine Treatment of CDBiological: MSC treatment 01

MSC-2

EXPERIMENTAL

Patients in this arms receive routine treatment with 6×10E6/kg of MSC

Drug: Routine Treatment of CDBiological: MSC treatment 02

Ctrl

PLACEBO COMPARATOR

Patients in this arms receive routine treatment with NS injection

Drug: Routine Treatment of CDOther: NS

Interventions

Routine Treatment of CDDRUG

The Drug including 6MP, AZA, infliximab and thalidomide

CtrlMSC-1MSC-2
MSC treatment 01BIOLOGICAL

Injection of 3×10E6/kg of MSC

MSC-1
MSC treatment 02BIOLOGICAL

Injection of 6×10E6/kg of MSC

MSC-2
NSOTHER

Injection of NS

Also known as: normal saline
Ctrl

Eligibility Criteria

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

You may qualify if:

  • Failure or intolerance to GC, immune inhibitors and biological agents treatment
  • CDAI between 250-450
  • Weight between 40-150 kg
  • Normal renal function
  • endoscopic or imaging diagnosis of CD in the small intestine, colon ileocolon
  • Signed informed consent

You may not qualify if:

  • HIV or active hepatitis patients;
  • Allergic to CT contrast agents, cattle or pig products;
  • Stricture or perforation type CD;
  • Recieved permanent colostomy;
  • Used biological preparation in 3 months
  • Used prednisone \> 20 mg/day within 1 month ;
  • Patients with short bowel syndrome;
  • Need total parenteral nutrition;
  • Liver meritorious service is abnormal;
  • Suffering from malignant tumor during the last 5 years;
  • Combined bacterial or viral enteritis;
  • Suffering from intestinal typicality thickening of the living
  • Patients with tuberculosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Crohn Disease

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

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 23, 2015

First Posted

August 26, 2015

Study Start

January 1, 2016

Primary Completion

November 1, 2018

Study Completion

December 1, 2018

Last Updated

August 26, 2015

Record last verified: 2015-08