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The Efficiency of MSC in Refractory Crohn's Disease

Primary Purpose

Crohn's Disease

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Routine Treatment of CD
MSC treatment 01
MSC treatment 02
NS
Sponsored by
Sixth Affiliated Hospital, Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring efficacy of MSC, refractory

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    MSC-1

    MSC-2

    Ctrl

    Arm Description

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

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

    Patients in this arms receive routine treatment with NS injection

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    August 23, 2015
    Last Updated
    August 25, 2015
    Sponsor
    Sixth Affiliated Hospital, Sun Yat-sen University
    Collaborators
    Third Affiliated Hospital, Sun Yat-Sen University, Nanfang Hospital, Southern Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02532738
    Brief Title
    The Efficiency of MSC in Refractory Crohn's Disease
    Official Title
    A Stage II Clinical Trial Comparing the Efficiacy of Routine Treatment Combined With or Without MSC Therapy in Refractory Crohn's Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2016 (undefined)
    Primary Completion Date
    November 2018 (Anticipated)
    Study Completion Date
    December 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Sixth Affiliated Hospital, Sun Yat-sen University
    Collaborators
    Third Affiliated Hospital, Sun Yat-Sen University, Nanfang Hospital, Southern Medical University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Crohn's Disease
    Keywords
    efficacy of MSC, refractory

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    3 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    MSC-1
    Arm Type
    Experimental
    Arm Description
    Patients in this arms receive routine treatment with 3×10E6/kg of MSC
    Arm Title
    MSC-2
    Arm Type
    Experimental
    Arm Description
    Patients in this arms receive routine treatment with 6×10E6/kg of MSC
    Arm Title
    Ctrl
    Arm Type
    Placebo Comparator
    Arm Description
    Patients in this arms receive routine treatment with NS injection
    Intervention Type
    Drug
    Intervention Name(s)
    Routine Treatment of CD
    Intervention Description
    The Drug including 6MP, AZA, infliximab and thalidomide
    Intervention Type
    Biological
    Intervention Name(s)
    MSC treatment 01
    Intervention Description
    Injection of 3×10E6/kg of MSC
    Intervention Type
    Biological
    Intervention Name(s)
    MSC treatment 02
    Intervention Description
    Injection of 6×10E6/kg of MSC
    Intervention Type
    Other
    Intervention Name(s)
    NS
    Other Intervention Name(s)
    normal saline
    Intervention Description
    Injection of NS
    Primary Outcome Measure Information:
    Title
    Clinical Response of CD patients 12 weeks after receiving treatment (Reduction of CDAI score at less 100)
    Description
    Reduction of CDAI score at less 100
    Time Frame
    12 weeks after receiving treatment
    Secondary Outcome Measure Information:
    Title
    Clinical Response of CD patients 6 weeks after receiving treatment (CDAI score less than 150)
    Description
    CDAI score less than 150
    Time Frame
    6 weeks after receiving treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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: 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.

    12. IPD Sharing Statement

    Learn more about this trial

    The Efficiency of MSC in Refractory Crohn's Disease

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