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Adipose Mesenchymal Stem Cells (AMSC) for Treatment of Ulcerative Colitis (AMSC_UC)

Primary Purpose

Ulcerative Colitis (UC)

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Adipose-cord mesenchymal stromal cells (A-MSCs)
Conventional drugs
Sponsored by
Liaocheng People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis (UC) focused on measuring ulcerative colitis (UC), mesenchymal stem cells(MSC)

Eligibility Criteria

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

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • Liaocheng city people's hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention group

Control group

Arm Description

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

interventions:Conventional drug therapy (5-amino-salicylic acid or glucocorticoid) is used

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from Baseline in clinical response (CDAI points)
CDAI is defined as Clinical Disease Activity Index
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.
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).
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.).
Incidence of Treatment Adverse.
An AE was any untoward medical occurrence in a participant

Full Information

First Posted
June 1, 2018
Last Updated
August 31, 2020
Sponsor
Liaocheng People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03609905
Brief Title
Adipose Mesenchymal Stem Cells (AMSC) for Treatment of Ulcerative Colitis
Acronym
AMSC_UC
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
December 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Liaocheng People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis (UC)
Keywords
ulcerative colitis (UC), mesenchymal stem cells(MSC)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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
Arm Title
Control group
Arm Type
Other
Arm Description
interventions:Conventional drug therapy (5-amino-salicylic acid or glucocorticoid) is used
Intervention Type
Biological
Intervention Name(s)
Adipose-cord mesenchymal stromal cells (A-MSCs)
Intervention Description
A-MSCs 5 x 10~7 diluted on 100 mL of normal saline
Intervention Type
Other
Intervention Name(s)
Conventional drugs
Intervention Description
5-amino-salicylic acid or glucocorticoid
Primary Outcome Measure Information:
Title
Change From Baseline in Endoscopic Score (as Measured by Ulcerative Colitis Endoscopic Index of Severity)
Description
Ulcerative Colitis Endoscopic Index of Severity (UCEIS) is defined as Ulcerative Colitis Endoscopic Index of Severity, with higher scores indicating more severe disease
Time Frame
Baseline, 8 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline in clinical response (CDAI points)
Description
CDAI is defined as Clinical Disease Activity Index
Time Frame
Baseline, 8 weeks
Title
To evaluate the quality of life index, Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
Description
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.
Time Frame
Baseline, 8 weeks
Title
Histologic Evaluation of Ulcerative Colitis
Description
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).
Time Frame
Baseline, 8 weeks
Title
Immune response in ulcerative colitis.
Description
A number of soluble mediators are detected, including proinflammatory cytokines (TNF, IFN-γ, IL-6.) and anti-inflammatory cytokines (IL-10, IL-4.).
Time Frame
Baseline, 1, 4, 8 weeks
Title
Incidence of Treatment Adverse.
Description
An AE was any untoward medical occurrence in a participant
Time Frame
Baseline, 1, 4, 8 weeks

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: 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) Exclusion Criteria: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shaoda Ren, Ph.D.
Phone
86-0635-8272202
Email
zslrsd@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peng Yan, MD
Organizational Affiliation
Liaocheng People's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Liaocheng city people's hospital
City
Liaocheng
State/Province
Shandong
ZIP/Postal Code
0635
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaoda Ren
Phone
86-0635-8272202
Email
zslrsd@163.com

12. IPD Sharing Statement

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Adipose Mesenchymal Stem Cells (AMSC) for Treatment of Ulcerative Colitis

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