Clinical research of Umbilical Cord–Derived Mesenchymal Stromal Cells in the Prophylaxis of Graft-Versus-Host Disease After HLA-Haploidentical Stem-Cell Transplantation

Clinical research of Umbilical Cord–Derived Mesenchymal Stromal Cells in the Prophylaxis of Graft-Versus-Host Disease After HLA-Haploidentical Stem-Cell Transplantation,a multicenter,randomized,controlled and open trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900022292

Enrollment

Unknown

Registered

2019-04-03

Start date

2019-04-02

Completion date

Unknown

Last updated

2019-04-08

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

Conditions

Graft Versus Host Disease

Interventions

Experimental group:On the basis of conventional GVHD prevention, UC-MSCs were infused 4 hours before transplantation of peripheral hematopoietic stem cell on 01 days in the test group. UC-MSCs (+7 day

UC-MSCs (+42 days, +56 days)&

Control group:(MMF) 0.5g q12h-7d-90d, Cyclosporine (CsA) 1.25mg/kg, continuous intravenous drip

- 1 day increment to 2.5mg/kg

patients can tolerate oral change to 5 mg/kg, the concentration maintained at 200-300 ng/ml

180 days after transplantation, slow reduction

Methotrexate (MTX) 15mg/m2 d1, 10mg/m2 d3, 6, 11)

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed as acute leukemia with haploid hematopoietic stem cell transplantation; 2. Male and female aged 18-60years; 3. KPS score>60, Estimated lifetime>3months; 4. Voluntary participants, informed consent.

Exclusion criteria

Exclusion criteria: 1. Severe cardiac, renal or hepatic dysfunction; 2. Patients have other malignant cancer and must receive treatment; 3. Patients cant understand or follow study protocol due to clinical symptoms of brain dysfunction or serious mental illness; 4. Patients can't guarantee to accomplish treatment plan and follow-up; 5. Patients with severe acute hypersensitive reaction; 6. Uncontrolled active infection; 7. Patients who have been enrolled in other clinical trial; 8. Patients aren't suitable for this clinical trial; 9. With serious impairment of important organs; Cr55%, Hb>9g/dL, Bilirubin<2.0mg/dl; 10. With other contraindication of hematopoietic stem cell transplantation; 11. according to investigators judgement.

Design outcomes

Primary

Measure	Time frame
rate of chronic graft versus host disease Incidence of chronic GVHD;	—

Secondary

Measure	Time frame
rate of acute graft versus host disease;1 year overall survival rate;1 year disease-free survival rate;Acute adverse events;	—

Countries

China

Contacts

Public ContactZhang Xi

Department of Hematology, Xinqiao Hospital of Army Medical University

zhangxxi@sina.com+86 023-68774509

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 20, 2026