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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Control group | Other | interventions:Conventional drug therapy (5-amino-salicylic acid or glucocorticoid) is used |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adipose-cord mesenchymal stromal cells (A-MSCs) | Biological | A-MSCs 5 x 10~7 diluted on 100 mL of normal saline |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in clinical response (CDAI points) | CDAI is defined as Clinical Disease Activity Index | Baseline, 8 weeks |
| To evaluate the quality of life index, Short Inflammatory Bowel Disease Questionnaire (SIBDQ) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shaoda Ren, Ph.D. | Contact | 86-0635-8272202 | zslrsd@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Peng Yan, MD | Liaocheng People's Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liaocheng city people's hospital | Recruiting | Liaocheng | Shandong | 0635 | China |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Conventional drugs | Other | 5-amino-salicylic acid or glucocorticoid |
|
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.
| 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). | 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.). | Baseline, 1, 4, 8 weeks |
| Incidence of Treatment Adverse. | An AE was any untoward medical occurrence in a participant | Baseline, 1, 4, 8 weeks |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |