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

Study Purpose

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.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

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Trial ID:
NCT03609905

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
Phase 1/Phase 2

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Liaocheng People's Hospital

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Peng Yan, MD
Principal Investigator Affiliation Liaocheng People's Hospital

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Other
Overall Status Recruiting
Countries China

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Ulcerative Colitis (UC)

Contact a Trial Team

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International Sites

Liaocheng city people's hospital, Liaocheng, Shandong, China

Status

Recruiting

Address

Liaocheng city people's hospital

Liaocheng, Shandong, 0635

Site Contact

Shaoda Ren

zslrsd@163.com

86-0635-8272202

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