Crohn's DiseasePhase 2/3NCT03056664
The Role of MSC in the Treatment of Fistulas in Patients With Perianal Crohn's Disease
A Phase 2/3 study testing Routine drainage surgery, MSC injection 01 and MSC injection 02 in people with Crohn's Disease and Fistula, run by Sixth Affiliated Hospital, Sun Yat-sen University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Crohn's Disease, Fistula
- What is being tested?
- Routine drainage surgery, MSC injection 01 and MSC injection 02
- Type of treatment
- Injection or infusion, Surgery or procedure
- 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 2017to Dec 2019
- 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
- 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.
Who cannot join
- 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;
Show all 16Show fewer
- 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;
- 17) In the past five years, those who suffer from cancer; 18) there is a history of lymphoproliferative disease.
About this study
Official title: The Safety and Efficiacy of Local MSC Injection in the Treatment of Fistulas in Patients With Perianal Crohn's Disease
Here investigators will carry out this phase II clinical trial to explore a effective therapeutic regimen of MSC in the Crohn's perianal fistula.
Read the detailed description
Peri-anal fistula is common seen in Crohn's disease. Treatments including surgery, antibiotics, immunosuppressive drug and infliximab improve the quality of life of the patients suffering Crohn's perianal fistula, but the recurrent rate is still high. MSC showed promising effect in the therapy of CD, but the standard treatment strategy is unclear. Here investigators will carry out this phase II clinical trial to explore a effective therapeutic regimen of MSC in the Crohn's perianal fistula.
- Conditions
- Crohn's Disease, Fistula
- Being tested
- Routine drainage surgery, MSC injection 01, MSC injection 02, placebo
- Medical subject headings
- Crohn Disease, Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine drainage surgeryProcedure or surgery
MSC injection 01Biological
Local MSC injection in peri-anal with a dose of 3×10E6/kg
MSC injection 02Biological
Local MSC injection in peri-anal with a dose of 6×10E6/kg
placeboOther
NS injection instead of MSC
| Study group | Role | What they receive |
|---|---|---|
| MSC-1 | Experimental | Patient in this arm will receive routine surgery and local MSC injection of 3×10E6/kg Receives: Procedure: Routine drainage surgery; Biological: MSC injection 01 |
| MSC-2 | Experimental | Patient in this arm will receive routine surgery and local MSC injection of 6×10E6/kg Receives: Procedure: Routine drainage surgery; Biological: MSC injection 02 |
| Ctrl | Experimental | Patient in this arm will receive routine surgery and local NS injection Receives: Procedure: Routine drainage surgery; Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response(fistula closure)
Physical examination indicates fistula healing, or MRI examinations showed fistula healing more than 2cm
Measured: 12 weeks
Secondary outcomes (2)
C-reactive protein (CRP)
To summarize the changes from baseline compared to 12 weeks in serum C-reactive protein (CRP)
Measured: 12 weeks
Clinical Response
CDAI means Crohn's Disease Activity Index.The purpose of this crohn's disease activity index (CDAI) calculator is to gauge the progress or lack of progress for people with crohn's disease. The reference article says "generally speaking, CDAI scores below 150 indicate a better prognosis than higher scores." Clinical Response of patients 6 weeks after receiving treatment (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 posted17 Feb 2017
- Study startJan 2017
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03056664
- Sponsor's protocol ID
- MSCINCDGL
- Status last verified
- Sep 2016
- First submitted
- 24 Aug 2015
- Last updated
- 17 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficiacy of Local MSC Injection in the Treatment of Fistulas in Patients With Perianal Crohn's Disease
- ClinicalTrials.gov ID
- NCT03056664
- Acronym / sponsor ID
- MSCINCDGL
- Conditions
- Crohn's Disease, Fistula
- 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
- Study start
- Jan 2017
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 17 Feb 2017 (actual)
- 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.
Here investigators will carry out this phase II clinical trial to explore a effective therapeutic regimen of MSC in the Crohn's perianal fistula.
Detailed description
Peri-anal fistula is common seen in Crohn's disease. Treatments including surgery, antibiotics, immunosuppressive drug and infliximab improve the quality of life of the patients suffering Crohn's perianal fistula, but the recurrent rate is still high. MSC showed promising effect in the therapy of CD, but the standard treatment strategy is unclear. Here investigators will carry out this phase II clinical trial to explore a effective therapeutic regimen of MSC in the Crohn's perianal fistula.
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 | Procedure: Routine drainage surgery, Biological: MSC injection 01Patient in this arm will receive routine surgery and local MSC injection of 3×10E6/kg |
| MSC-2 | Experimental | Procedure: Routine drainage surgery, Biological: MSC injection 02Patient in this arm will receive routine surgery and local MSC injection of 6×10E6/kg |
| Ctrl | Experimental | Procedure: Routine drainage surgery, Other: placeboPatient in this arm will receive routine surgery and local 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)
- 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);
Key exclusion criteria (16 listed)
- 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;
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 drainage surgery | Procedure or surgery | Ctrl, MSC-1, MSC-2 |
| MSC injection 01Local MSC injection in peri-anal with a dose of 3×10E6/kg | Biological | MSC-1 |
| MSC injection 02Local MSC injection in peri-anal with a dose of 6×10E6/kg | Biological | MSC-2 |
| placeboNS injection instead of MSC | Other | Ctrl |
Primary outcome
Clinical response(fistula closure)
Time frame: 12 weeks
Physical examination indicates fistula healing, or MRI examinations showed fistula healing more than 2cm
2 secondary outcomes
C-reactive protein (CRP)
Time frame: 12 weeks
Clinical Response
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 17 Feb 2017.
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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 drainage surgery, MSC injection 01 and MSC injection 02 in people with Crohn's Disease and Fistula, 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 16 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 17 Feb 2017. 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. 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(fistula closure) (time frame: 12 weeks). 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 17 Feb 2017.