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

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ClinicalTrials.gov Identifier: NCT03609905
Recruitment Status : Recruiting
First Posted : August 1, 2018
Last Update Posted : August 2, 2018
Sponsor:
Information provided by (Responsible Party):
peng yan, Liaocheng People's Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis (UC) Biological: Adipose-cord mesenchymal stromal cells (A-MSCs) Other: Conventional drugs Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : February 1, 2019
Estimated Study Completion Date : February 1, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention group
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
 Biological: Adipose-cord mesenchymal stromal cells (A-MSCs)
A-MSCs 5 x 10~7 diluted on 100 mL of normal saline

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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Change from Baseline in clinical response (CDAI points) [ Time Frame: Baseline, 8 weeks ]
    CDAI is defined as Clinical Disease Activity Index

  2. To evaluate the quality of life index, Short Inflammatory Bowel Disease Questionnaire (SIBDQ) [ Time Frame: Baseline, 8 weeks ]
    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.

  3. Histologic Evaluation of Ulcerative Colitis [ Time Frame: Baseline, 8 weeks ]
    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).

  4. Immune response in ulcerative colitis. [ Time Frame: Baseline, 1, 4, 8 weeks ]
    A number of soluble mediators are detected, including proinflammatory cytokines (TNF, IFN-γ, IL-6.) and anti-inflammatory cytokines (IL-10, IL-4.).

  5. Incidence of Treatment Adverse. [ Time Frame: Baseline, 1, 4, 8 weeks ]
    An AE was any untoward medical occurrence in a participant


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03609905


Contacts
Contact: Shaoda Ren, Ph.D. 86-0635-8272202 zslrsd@163.com

Locations
China, Shandong
Liaocheng city people's hospital Recruiting
Liaocheng, Shandong, China, 0635
Contact: Shaoda Ren    86-0635-8272202    zslrsd@163.com   
Sponsors and Collaborators
Liaocheng People's Hospital
Investigators
Study Chair: Peng Yan, MD Liaocheng People's Hospital
More Information
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Responsible Party: peng yan, Chief of gastroenterology, Liaocheng People's Hospital
ClinicalTrials.gov Identifier: NCT03609905     History of Changes
Other Study ID Numbers: lcsrmyy-yp1
First Posted: August 1, 2018    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: July 2018

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

Keywords provided by peng yan, Liaocheng People's Hospital:
ulcerative colitis (UC)
mesenchymal stem cells(MSC)

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Glucocorticoids
Salicylic Acid
Salicylates
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
 Physiological Effects of Drugs
Anti-Infective Agents
Antifungal Agents
Keratolytic Agents
Dermatologic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action