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Clinical study of umbilical cord blood mononuclear cell therapy for the treatment of steroid-resistant or dependent ulcerative colitis patients

Clinical study of umbilical cord blood mononuclear cell therapy for the treatment of steroid-resistant or dependent ulcerative colitis patients

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200059177
Enrollment
Unknown
Registered
2022-04-26
Start date
2022-04-26
Completion date
Unknown
Last updated
2024-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative colitis

Interventions

Experimental group:Submucosal injection of umbilical cord blood mononuclear cells

Sponsors

Provincial Hospital Affiliated to Shandong First Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18-65 years; 2. Clearly understand the purpose and nature of treatment and sign informed consent; 3. Colonoscopy and histopathology examination were performed within 1 month before inclusion of the treatment, and UC was diagnosed with Mayo score >=6 and endoscopic score >=2; 4. Patients with hormone resistance: the disease did not relieve after 4 weeks of treatment equivalent to prednisone 0.75mg/kg/d; 5. Hormone-dependent patients: although they can maintain remission of the disease, prednisone cannot be reduced to 10mg/d for 3 months after hormone therapy, or relapse for 3 months after drug withdrawal; 6. Patients who have used at least one type of biological agent with unsatisfactory therapeutic results; 7. Patients have the ability to answer the questionnaire.

Exclusion criteria

Exclusion criteria: 1. Patients of latent tuberculosis infection, active tuberculosis and viral hepatitis B, patients with repeated chronic infection of unknown cause; 2. Patients with heart failure; 3. Pregnant and lactating patients and children; 4. Patients with malignant tumors (including present disease and past history); 5. Have infectious colitis (intestinal disease caused by parasites, eggs or bacteria); 6. Crohn's disease; 7. Acute abdomen; 8. Patients who have participated in clinical trials of other drugs within the last three months; 9. Those who have participated in fecal bacteria transplantation within the last three months; 10. Patients with other unstable conditions that the physician deems unsuitable for treatment.

Design outcomes

Primary

MeasureTime frame
Modified Truelove and Witts disease severity classification;

Countries

China

Contacts

Public ContactXu Hongwei

Provincial Hospital Affiliated to Shandong First Medical University

xhwsdslyy@sina.com+86 15168889328

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026