Ulcerative Colitis (UC)Phase 1/2AMSC_UCNCT03609905
Adipose Mesenchymal Stem Cells (AMSC) for Treatment of Ulcerative Colitis
A Phase 1/2 study testing Adipose-cord mesenchymal stromal cells (A-MSCs) and Conventional drugs in people with Ulcerative Colitis (UC), run by Liaocheng People's Hospital at 1 site in China.
Trial summary
Ulcerative colitis is a form of inflammatory bowel disease characterized by diffuse inflammation of the colonic mucosa. It affects the rectum and extends proximally along a variable length of the colon. Ulcerative colitis is a chronic condition with a relapsing remitting course. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ulcerative Colitis (UC)
- What is being tested?
- Adipose-cord mesenchymal stromal cells (A-MSCs) and Conventional drugs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2018to 1 Dec 2021
- Phase
- Phase 1/2
- 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
- Male or female, 18-65 years old
- Diagnosis of ulcerative colitis diagnosed at least 6 months earlier
- Moderate or severe activity defined by a Mayo score
- No serious infection, chronic diseases, diabetes and tuberculosis
- Unefficient by using 5-ASA, glucocorticoid or azathioprine
- Written informed consents were obtained from all subjects
- Capable of good communication with researchers and follow the entire test requirements
- Negative pregnancy test for women of childbearing potential (from menarche to menopause)
Who cannot join
- Pregnant or breastfeeding women or cognitively impaired adults
- History of malignant disease
- Infectious colitis
- Patients with known allergies to culture medium
- Patients having participated in clinical trials with any investigational drug within 1 month prior to enrolment in this study
- Patients with suspicion of Crohn's enterocolitis, indeterminate colitis, ischaemic colitis, radiation colitis, diverticular disease associated colitis, or microscopic colitis
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- Patients with previous colectomy
- Positive to one or more of the infectious disease panel
- Treatment with surgery or biological treatment (infliximab or adamizumab) or Cyclosporine or tacrolimus or mycophenolate in the 8 weeks prior to inclusion in the study
- Presence of severe concomitant diseases
- Patients with clostridium difficult or cytomegalovirus infection
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Liaocheng city people's hospital
Liaocheng, Shandong, 0635
Shaoda Ren, 86-0635-8272202, zslrsd@163.com
About this study
Official title: A Phase I/II Randomized, Controlled, Clinical Trial for Assessment of the Safety and Efficacy of Allogeneic Adipose Mesenchymal Stem Cells in Moderate to Severe Ulcerative Colitis Patients
Ulcerative colitis is a form of inflammatory bowel disease characterized by diffuse inflammation of the colonic mucosa. It affects the rectum and extends proximally along a variable length of the colon. Ulcerative colitis is a chronic condition with a relapsing remitting course. Mesenchymal stem cells (MSCs) are a subset of adult stem cells residing in many tissues, including bone marrow (BM), adipose tissue, umbilical cord blood. Recent experimental findings have shown the ability of MSCs to home to damaged tissues and to produce paracrine factors with anti-inflammatory properties, potentially resulting in reduction of inflammation and functional recovery of the damaged tissues. The purpose of our study is to evaluate safety and efficacy of the intracolonic injection by using a colonoscope of allogeneic adipose MSCs in patients with moderate active ulcerative colitis.
- Conditions
- Ulcerative Colitis (UC)
- Being tested
- Adipose-cord mesenchymal stromal cells (A-MSCs), Conventional drugs
- Keywords
- ulcerative colitis (UC), mesenchymal stem cells(MSC)
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adipose-cord mesenchymal stromal cells (A-MSCs)Biological
A-MSCs 5 x 10~7 diluted on 100 mL of normal saline
Conventional drugsOther
5-amino-salicylic acid or glucocorticoid
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | interventions: The MSCs of 5×10*7 will be given in different sites within colonic submucosa at a total 100 ml with the use of the colonoscope. Once every week，a total of two times. Conventional drug therapy (5-amino-salicylic acid or glucocorticoid) is used Receives: Biological: Adipose-cord mesenchymal stromal cells (A-MSCs); Other: Conventional drugs |
| Control group | Other | interventions:Conventional drug therapy (5-amino-salicylic acid or glucocorticoid) is used Receives: Other: Conventional drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Endoscopic Score (as Measured by Ulcerative Colitis Endoscopic Index of Severity)
Ulcerative Colitis Endoscopic Index of Severity (UCEIS) is defined as Ulcerative Colitis Endoscopic Index of Severity, with higher scores indicating more severe disease
Measured: Baseline, 8 weeks
Secondary outcomes (5)
Change from Baseline in clinical response (CDAI points)
CDAI is defined as Clinical Disease Activity Index
Measured: Baseline, 8 weeks
To evaluate the quality of life index, Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) is a health-related quality of life (HRQoL) tool measuring physical, social, and emotional status. It includes 10-item form of questions. Each question is scored on a Likert scale from 1 (worst) to 7 (best), scores from each item are summed to produce a total score, increased more than 3 scores were considered remission.
Measured: Baseline, 8 weeks
Histologic Evaluation of Ulcerative Colitis
A 10 to 20 centimeter (cm) biopsy sample of inflamed mucosal tissue was taken from the worst affected area and scored using the Riley Index. The Riley Index is a histologic scoring system for the assessment of the activity and severity of ulcerative colitis, ranging from 0 to 24. It consists of 6 histologic features (acute inflammatory cell infiltrate, crypt abscesses, mucin depletion, surface epithelial integrity, chronic inflammatory cell infiltrate, and crypt architectural irregularities), all scored on a 4-point scale (higher scores indicate more severe disease).
Measured: Baseline, 8 weeks
Immune response in ulcerative colitis.
A number of soluble mediators are detected, including proinflammatory cytokines (TNF, IFN-γ, IL-6.) and anti-inflammatory cytokines (IL-10, IL-4.).
Measured: Baseline, 1, 4, 8 weeks
Incidence of Treatment Adverse.
An AE was any untoward medical occurrence in a participant
Measured: Baseline, 1, 4, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start1 Jul 2018
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis (UC)Studies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liaocheng People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, peng yan, Liaocheng People's Hospital
- Investigators
- Peng Yan, MD, Study chair, Liaocheng People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03609905
- Sponsor's protocol ID
- lcsrmyy-yp1
- Acronym
- AMSC_UC
- Status last verified
- Aug 2020
- First submitted
- 1 Jun 2018
- Last updated
- 2 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Randomized, Controlled, Clinical Trial for Assessment of the Safety and Efficacy of Allogeneic Adipose Mesenchymal Stem Cells in Moderate to Severe Ulcerative Colitis Patients
- ClinicalTrials.gov ID
- NCT03609905
- Acronym / sponsor ID
- AMSC_UC / lcsrmyy-yp1
- Conditions
- Ulcerative Colitis (UC)
- Keywords
- ulcerative colitis (UC), mesenchymal stem cells(MSC)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Liaocheng People's HospitalUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 1 Aug 2018 (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.
Ulcerative colitis is a form of inflammatory bowel disease characterized by diffuse inflammation of the colonic mucosa. It affects the rectum and extends proximally along a variable length of the colon. Ulcerative colitis is a chronic condition with a relapsing remitting course. Mesenchymal stem cells (MSCs) are a subset of adult stem cells residing in many tissues, including bone marrow (BM), adipose tissue, umbilical cord blood. Recent experimental findings have shown the ability of MSCs to home to damaged tissues and to produce paracrine factors with anti-inflammatory properties, potentially resulting in reduction of inflammation and functional recovery of the damaged tissues. The purpose of our study is to evaluate safety and efficacy of the intracolonic injection by using a colonoscope of allogeneic adipose MSCs in patients with moderate active ulcerative colitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Biological: Adipose-cord mesenchymal stromal cells (A-MSCs), Other: Conventional drugsinterventions: The MSCs of 5×10*7 will be given in different sites within colonic submucosa at a total 100 ml with the use of the colonoscope. Once every week，a total of two times. Conventional drug therapy (5-amino-salicylic acid or glucocorticoid) is used |
| Control group | Other | Other: Conventional drugsinterventions:Conventional drug therapy (5-amino-salicylic acid or glucocorticoid) is used |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female, 18-65 years old
- Diagnosis of ulcerative colitis diagnosed at least 6 months earlier
- Moderate or severe activity defined by a Mayo score
- No serious infection, chronic diseases, diabetes and tuberculosis
- Unefficient by using 5-ASA, glucocorticoid or azathioprine
Key exclusion criteria (11 listed)
- Pregnant or breastfeeding women or cognitively impaired adults
- History of malignant disease
- Infectious colitis
- Patients with known allergies to culture medium
- Patients having participated in clinical trials with any investigational drug within 1 month prior to enrolment in this study
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 |
|---|---|---|
| Adipose-cord mesenchymal stromal cells (A-MSCs)A-MSCs 5 x 10~7 diluted on 100 mL of normal saline | Biological | Intervention group |
| Conventional drugs5-amino-salicylic acid or glucocorticoid | Other | Control group, Intervention group |
Primary outcome
Change From Baseline in Endoscopic Score (as Measured by Ulcerative Colitis Endoscopic Index of Severity)
Time frame: Baseline, 8 weeks
Ulcerative Colitis Endoscopic Index of Severity (UCEIS) is defined as Ulcerative Colitis Endoscopic Index of Severity, with higher scores indicating more severe disease
5 secondary outcomes
Change from Baseline in clinical response (CDAI points)
Time frame: Baseline, 8 weeks
To evaluate the quality of life index, Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
Time frame: Baseline, 8 weeks
Histologic Evaluation of Ulcerative Colitis
Time frame: Baseline, 8 weeks
Immune response in ulcerative colitis.
Time frame: Baseline, 1, 4, 8 weeks
Incidence of Treatment Adverse.
Time frame: Baseline, 1, 4, 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
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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.
Peng Yan, MD study chair
Liaocheng People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Adipose-cord mesenchymal stromal cells (A-MSCs) and Conventional drugs in people with Ulcerative Colitis (UC), run by Liaocheng People's Hospital at 1 site in China.
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 8 inclusion and 11 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 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Shaoda Ren, Ph.D. (86-0635-8272202, zslrsd@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Endoscopic Score (as Measured by Ulcerative Colitis Endoscopic Index of Severity) (time frame: Baseline, 8 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 2 Sep 2020.