Status:
UNKNOWN
Clinical Study of Cord Blood Mononuclear Cells on Treatment of Hormone-resistant or Hormone-dependent Ulcerative Colitis
Lead Sponsor:
Shandong Qilu Stem Cells Engineering Co., Ltd.
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-65 years
Phase:
NA
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 clini...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04882683
Start Date
June 1 2021
End Date
December 31 2022
Last Update
May 12 2021
Active Locations (1)
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1
The Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Shandong, Shandong, China