Clinical trial NCT04882683: Clinical Study of Cord Blood Mononuclear Cells on Treatment of Hormone-resistant or Hormone-dependent Ulcerative Colitis
Official title: Clinical Study of Cord Blood Mononuclear Cells on Treatment of Hormone-resistant or Hormone-dependent Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ulcerative Colitis
Keywords: Ulcerative colitis
umbilical cord blood mononuclear cells
safety and efficacy
Lead sponsor: Shandong Qilu Stem Cells Engineering Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-05-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study conducted a systematic clinical observation of the clinical efficacy of UCB-MNCs in the treatment of hormone-resistant or hormone-dependent ulcerative colitis, in order to observe its clinical safety and efficacy.

Detailed description: This study adopts a randomized and controlled clinical research design. Patients are randomly divided into conventional treatment control group and UCB-MNCs treatment test group. The control group is given conventional treatment: prednisone combined azathioprine or adalimumab; the test group is given conventional treatment combined UCB-MNCs treatment, follow-up observations were carried out, in order to observe the clinical efficacy and safety of UCB-MNCs in the treatment of hormone resistance or hormone-dependent ulcerative colitis.

Eligibility criteria: Inclusion Criteria:

* 1. Western medicine diagnosis is consistent with patients with refractory ulcerative colitis.
* 2. 18 Years to 65 Years，male or female.
* 3. Those who voluntarily participate in this clinical study and have signed an informed consent.

Exclusion Criteria:

* 1. Patients with non-refractory UC.
* 2. Those who are pregnant or breastfeeding, or have a childbirth plan in the near future.
* 3. People with severe allergies or allergies to known ingredients in basic treatments.
* 4. Patients with severe primary diseases such as severe cardiovascular and cerebrovascular diseases, liver and kidney, and hematopoietic system.
* 5. There are serious complications, such as local stenosis, intestinal obstruction, intestinal perforation, multiple intestinal polyps, toxic megacolon, rectal cancer, etc..
* 6. Patients with mental disorders and intellectual disabilities.
* 7. Patients who have participated in clinical studies of other drugs in the past 3 months.
* 8. Those who are seriously ill and need emergency treatment.
* 9. Patients who are still undergoing other treatment options for ulcerative colitis.
* 10. Researchers believe that it is not suitable for entry.

Primary outcomes:
measure: Clinical efficacy rate
timeFrame: Change from Baseline Clinical efficacy rate at 8th and 16th week, and the first week after the end of treatment.
measure: Clinical response rate
timeFrame: Change from Baseline Clinical response rate at 8th and 16th week, and the first week after the end of treatment.
Secondary outcomes:
measure: Clinical symptom score
timeFrame: Change from Baseline clinical symptom score at the first week after the end of treatment.
measure: Endoscopic response rate
timeFrame: Change from Baseline endoscopic response rate at the first week after the end of treatment.
measure: Mucosal healing rate
timeFrame: Change from Baseline mucosal healing rate at the first week after the end of treatment.
Other outcomes:
Locations:
city: Shandong
country: China
facility: The Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine
state: Shandong
Study officials:
References: