NCT04882683

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Shandong Qilu Stem Cells Engineering Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2021-06-01
• Primary completion: 2022-06-01
• Completion: 2022-12-31
• First posted: 2021-05-12
• Last updated: 2021-05-12

Locations

1 site across 1 country: China