Ulcerative Colitis
Conditions
Keywords
cellular therapy, active ulcerative colitis, phase 1/2 clinical study, human umbilical cord mesenchymal stem cell, allogeneic stem cell transplantation, UC
Brief summary
Phase I-II Clinical Trial - Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with active ulcerative colitis，randomized, single blind, controlled prospective study.
Detailed description
Phase I-II Clinical Trial - Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with active ulcerative colitis，randomized, single blind, controlled prospective study. Thirty patients will be selected and randomized into two groups: the first group of 15 patients will receive a sole injection of UC-MSC and the remaining 15 patients will comprise the control group. Every patient will maintain their standard treatment of active ulcerative colitis, with maximum tolerated dosage without side effects. The day of infusion will be considered day zero. From that moment, followup will be divided into 0-1 week, 1 week-2 week,2 week-3 week, 3 week-1 month, and 3 month-6 months. Clinical results will be analyzed after completion of 6 months of followup.
Interventions
BIOLOGICALUCMSC group
Human umbilical cord MSCs are transplanted three times by intravenous infusion(1×10\^6/kg) ,once every week，a total of three times.
Normal saline in same volume as MSCs are transplanted to patients.
Sponsors
Ivy Institute of Stem Cells Co. Ltd
Affiliated Hospital to Academy of Military Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* The diagnosis of active UC must have been confirmed by endoscopic and histological evidence. * With mild and moderate disease. * Men and women 18-65 years of age. * Signed informed consent * Capable of good communication with researchers and follow the entire test requirements
Exclusion criteria
* Patient with associated diseases such as diabetes mellitus, hypertension, dyslipidemia, atherosclerosis and malabsorption syndrome. * With autoimmune diseases (lupus, HIV, cancer and hepatitis), colitis (infectious, post-radiation, post-drug, indeterminate) and Crohn's Disease. * Abnormal hepatic or renal function * Prior history of malignancy * Pregnant or unwilling to practice contraceptive therapy or breast feeding females
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety will be determined by the assessment of major adverse events. | Within the six months after intravenous infusion | Safety will be determined by the assessment of major adverse events defined as fever, allergy or any other intravenous infusion adverse events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical response (CDAI points) | Post first cell transplantation: 3 weeks and months 1,3 and 6 | CDAI is defined as Clinical Disease Activity Index. |
| Endoscopic improvement is assessed by UCEIS. | Post first cell transplantation 6 months | UCEIS is defined as Ulcerative Colitis Endoscopic Index of Severity. |
| Level of C-reactive protein | Post first cell transplantation: 3 weeks and months 1,3 and 6 | — |
Countries
China
Contacts
Primary ContactYan Liu, M.D.
Outcome results
None listed