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Status unknownNCT02532738Updated Aug 26, 2015

The Efficiency of MSC in Refractory Crohn's Disease

A Phase 2/3 interventional study of Routine Treatment of CD and MSC treatment 01 in Crohn's Disease, sponsored by Sixth Affiliated Hospital, Sun Yat-sen University. Status unknown. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-08-26.

Sponsored by Sixth Affiliated Hospital, Sun Yat-sen University · Phase 2/3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2015), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2/3
Study type
Interventional
Enrollment
3
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Crohn's Disease

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Keywords

  • efficacy of MSC
  • refractory
03

In context

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

This study's planned enrollment of 3 is below the median of 66 across 1,188 interventional studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University is the lead sponsor of 211 studies on the registry; 110 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
3 participants (estimated)

Study arms

  • Experimental
    MSC-1

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

    Drug: Routine Treatment of CD · Biological: MSC treatment 01

  • Experimental
    MSC-2

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

    Drug: Routine Treatment of CD · Biological: MSC treatment 02

  • Placebo comparator
    Ctrl

    Patients in this arms receive routine treatment with NS injection

    Drug: Routine Treatment of CD · Other: NS

Interventions

  • DrugRoutine Treatment of CD

    The Drug including 6MP, AZA, infliximab and thalidomide

  • BiologicalMSC treatment 01

    Injection of 3×10E6/kg of MSC

  • BiologicalMSC treatment 02

    Injection of 6×10E6/kg of MSC

  • OtherNS

    Injection of NS

    Also known as: normal saline

06

What researchers measure

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

    Time frame: 12 weeks after receiving treatment

Secondary outcomes

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

    CDAI score less than 150

    Time frame: 6 weeks after receiving treatment

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02532738
Lead sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Collaborators
Third Affiliated Hospital, Sun Yat-Sen University, Nanfang Hospital, Southern Medical University
Responsible party
Sponsor
First posted
Aug 26, 2015
Start date
Jan 2016
Primary completion
Nov 2018 (estimated)
Completion
Dec 2018 (estimated)
Last update
Aug 26, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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