Umbilical Cord Mesenchymal Stem Cell Treatment for Crohn's Disease

900 Hospital of the People's Liberation Army Joint Logistic Support Force

Status and phase: Completed; Phase 2; Phase 1

Conditions: Crohn Disease

Treatments: Drug: received hormone maintenance therapy; Other: UC-MSCs by peripheral intravenous infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT02445547

UCMSC-CD

Details and patient eligibility

About

Stem cell transplantation has emerged as a relatively popular treatment that can help to regulate immunity, repair injury, and control inflammation. Several studies have used autologous stem cells or adipose-derived stem cells to treat Crohn's disease and its associated complications, and have achieved good efficacy. Thus far, the use of umbilical cord mesenchymal stem cells (UC-MSCs) to treat Crohn's disease has rarely been reported. In this study, UC-MSCs were used to treat patients with hormone-controlled Crohn's disease. We observed the disease control conditions, corticosteroid dosage changes, and treatment-related adverse reactions.

Enrollment: 82 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• above 18 years of age
• moderate to severe Crohn's disease (Crohn's disease activity index (CDAI) between 220 and 450)
• had received hormone maintenance therapy for more than 6 months

Exclusion criteria

• active tuberculosis
• malignancy
• HIV
• syphilis
• hepatitis B
• hepatitis C

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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82 participants in 2 patient groups

UC-MSCs

Experimental group

Description:

UC-MSCs by peripheral intravenous infusion

Treatment:

Other: UC-MSCs by peripheral intravenous infusion

control

Active Comparator group

Description:

received hormone maintenance therapy

Treatment:

Drug: received hormone maintenance therapy