Clinical Study of Cord Blood Mononuclear Cells on Treatment of Hormone-resistant or Hormone-dependent Ulcerative Colitis

Shandong Qilu Stem Cells Engineering

Status: Unknown

Conditions: Ulcerative Colitis

Treatments: Biological: umbilical cord blood mononuclear cells; Drug: Prednisone; Drug: Adalimumab; Drug: Azathioprine

Study type: Interventional

Funder types: Industry

Identifiers

NCT04882683

UCB-MNCs-UC-2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

control group

Experimental group

Description:

Prednisone+Azathioprine/Adalimumab

Treatment:

Drug: Adalimumab

Drug: Azathioprine

Drug: Prednisone

UCB-MNCs group

Experimental group

Description:

Prednisone+Azathioprine/Adalimumab+UCB-MNCs

Treatment:

Drug: Adalimumab

Drug: Azathioprine

Biological: umbilical cord blood mononuclear cells

Drug: Prednisone