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

Sponsor
Shandong Qilu Stem Cells Engineering Co., Ltd.
Study ID
NCT04882683
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Prednisone — DRUG
    0.75 mg per kilogram per day for three months
  • Azathioprine — DRUG
    1 mg per kilogram per day for three months
  • Adalimumab — DRUG
    40mg every two weeks for three months
  • umbilical cord blood mononuclear cells — BIOLOGICAL
    Peripheral intravenous infusion method, infusion of umbilical cord blood mononuclear cell suspension 50ml (cell number 2×10\^8).

Study Details

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.

Key Dates

Start date
Jun 1, 2021
Status verified
May 2021
Primary completion
Jun 1, 2022
Completion
Dec 31, 2022

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: control group
    Prednisone+Azathioprine/Adalimumab
  • Experimental: UCB-MNCs group
    Prednisone+Azathioprine/Adalimumab+UCB-MNCs

Primary Outcome Measure

Clinical efficacy rate [ Time Frame: Change from Baseline Clinical efficacy rate at 8th and 16th week, and the first week after the end of treatment. ]

Central Contacts

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