Crohn's DiseasePhase 2/3NCT02532738
The Efficiency of MSC in Refractory Crohn's Disease
A Phase 2/3 study testing Routine Treatment of CD, MSC treatment 01 and MSC treatment 02 in people with Crohn's Disease, run by Sixth Affiliated Hospital, Sun Yat-sen University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Routine Treatment of CD, MSC treatment 01 and MSC treatment 02
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Dec 2018
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 ;
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- 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.
About this study
Official title: A Stage II Clinical Trial Comparing the Efficiacy of Routine Treatment Combined With or Without MSC Therapy in Refractory Crohn's Disease
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.
- Conditions
- Crohn's Disease
- Being tested
- Routine Treatment of CD, MSC treatment 01, MSC treatment 02, NS
- Keywords
- efficacy of MSC, refractory
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine Treatment of CDDrug
The Drug including 6MP, AZA, infliximab and thalidomide
MSC treatment 01Biological
Injection of 3×10E6/kg of MSC
MSC treatment 02Biological
Injection of 6×10E6/kg of MSC
NSOther
Also called normal saline
Injection of NS
| Study group | Role | What they receive |
|---|---|---|
| MSC-1 | Experimental | Patients in this arms receive routine treatment with 3×10E6/kg of MSC Receives: Drug: Routine Treatment of CD; Biological: MSC treatment 01 |
| MSC-2 | Experimental | Patients in this arms receive routine treatment with 6×10E6/kg of MSC Receives: Drug: Routine Treatment of CD; Biological: MSC treatment 02 |
| Ctrl | Placebo comparator | Patients in this arms receive routine treatment with NS injection Receives: Drug: Routine Treatment of CD; Other: NS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Response of CD patients 12 weeks after receiving treatment (Reduction of CDAI score at less 100)
Reduction of CDAI score at less 100
Measured: 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
Measured: 6 weeks after receiving treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2015 (estimated)
- Study startJan 2016
- Primary completionNov 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Third Affiliated Hospital, Sun Yat-Sen University, Nanfang Hospital, Southern Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02532738
- Sponsor's protocol ID
- MSCINRCD
- Status last verified
- Aug 2015
- First submitted
- 23 Aug 2015
- Last updated
- 26 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Stage II Clinical Trial Comparing the Efficiacy of Routine Treatment Combined With or Without MSC Therapy in Refractory Crohn's Disease
- ClinicalTrials.gov ID
- NCT02532738
- Acronym / sponsor ID
- MSCINRCD
- Conditions
- Crohn's Disease
- Keywords
- efficacy of MSC, refractory
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Third Affiliated Hospital, Sun Yat-Sen University, Nanfang Hospital, Southern Medical University
- Study start
- Jan 2016
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 26 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MSC-1 | Experimental | Drug: Routine Treatment of CD, Biological: MSC treatment 01Patients in this arms receive routine treatment with 3×10E6/kg of MSC |
| MSC-2 | Experimental | Drug: Routine Treatment of CD, Biological: MSC treatment 02Patients in this arms receive routine treatment with 6×10E6/kg of MSC |
| Ctrl | Placebo comparator | Drug: Routine Treatment of CD, Other: NSPatients in this arms receive routine treatment with NS injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine Treatment of CDThe Drug including 6MP, AZA, infliximab and thalidomide | Drug | Ctrl, MSC-1, MSC-2 |
| MSC treatment 01Injection of 3×10E6/kg of MSC | Biological | MSC-1 |
| MSC treatment 02Injection of 6×10E6/kg of MSC | Biological | MSC-2 |
| NSAlso: normal salineInjection of NS | Other | Ctrl |
Primary outcome
Clinical Response of CD patients 12 weeks after receiving treatment (Reduction of CDAI score at less 100)
Time frame: 12 weeks after receiving treatment
Reduction of CDAI score at less 100
1 secondary outcome
Clinical Response of CD patients 6 weeks after receiving treatment (CDAI score less than 150)
Time frame: 6 weeks after receiving treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Routine Treatment of CD, MSC treatment 01 and MSC treatment 02 in people with Crohn's Disease, run by Sixth Affiliated Hospital, Sun Yat-sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Response of CD patients 12 weeks after receiving treatment (Reduction of CDAI score at less 100) (time frame: 12 weeks after receiving treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2015.