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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04882683
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Shandong Qilu Stem Cells Engineering Co., Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Ulcerative Colitis
Additional Details

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.

Arms & Interventions

Arms

Experimental: control group

Prednisone+Azathioprine/Adalimumab

Experimental: UCB-MNCs group

Prednisone+Azathioprine/Adalimumab+UCB-MNCs

Interventions

Drug: - Prednisone

0.75 mg per kilogram per day for three months

Drug: - Azathioprine

1 mg per kilogram per day for three months

Drug: - Adalimumab

40mg every two weeks for three months

Biological: - umbilical cord blood mononuclear cells

Peripheral intravenous infusion method, infusion of umbilical cord blood mononuclear cell suspension 50ml (cell number 2×10^8).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Shandong, Shandong, China

Status

Recruiting

Address

The Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Shandong, Shandong,

Site Contact

xueliang Jiang

jiangxueliang678@126.com

+86-15954103609