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

NCT04882683 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-05-12

No results posted yet for this study

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.

Conditions

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).

Sponsors & Collaborators

  • Shandong Qilu Stem Cells Engineering Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2022-06-01
Completion
2022-12-31

Countries

  • China

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04882683 on ClinicalTrials.gov