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Effect of co-infusion third party umbilical cord blood stem cells on haploidentical hematopoietic stem cell transplantation

Effect of co-infusion third party umbilical cord blood stem cells on haploidentical hematopoietic stem cell transplantation

Status
Recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OIN-17011426
Enrollment
Unknown
Registered
2017-05-17
Start date
2017-05-22
Completion date
Unknown
Last updated
2017-05-22

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

Conditions

Hematological disease

Interventions

haploidentical HSCT group:mobilized peripheral blood stem cells and low count of unrelated umbilical cord blood stem cells co-infusion
HLA-matched related HSCT group:mobilized peripheral blood stem cells alone

Sponsors

Tianjin First Center Hospita
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. The patient or his/her legal guardians must sign a consent form; 2. The patients therapeutic regimen is approved by the hospital ethics committee; 3. Aged 18-55, males and females; 4. Hematopoietic diseases: acute myeloid leukemia, acute lymphoblastic leukemia, Chronic leukemia, severe aplastic anemia, myelodysplastic syndrome, have transplant indication; 5. No sever function diseases in heart, brain, lung, liver or kidney or other organs; 6. Acute leukemia achieve complete remission before transplantation and without CNS or extramedullary infiltration; 7. Karnofsky score is more than 60%, Eastern Cooperative Oncology Group (ECOG) physical status score 0-2; 8. Volunteers can be followed up for the treatment effect after transplantation.

Exclusion criteria

Exclusion criteria: 1. pregnant or lactating women; 2. severe organ dysfunction or disease, such as heart, liver, kidney and pancreas and other severe diseases and dysfunction; 3. Not suitable for HSCT; 4. uncontrolled active infection within 4 weeks; 5. other cancers; 6. have taken part in other clinical tests within 6 weeks; 7. have a history of central nervous system disease; 8. addicted to some drugs; 9. the central nervous system and other organs were treated with maximum tolerated radiotherapy within 6 months; 10. the researchers think it is not suitable for the test; 11. The donor does not meet the requirements: HIV positive, active hepatitis B or C, bone marrow disease, onset of mental illness, poison, drug addiction, refused to donate peripheral blood, etc.

Design outcomes

Primary

MeasureTime frame
donor engraftment time;incidence and severity of graft-versus-host disease(GVHD),;recurrence rate of primary disease;DFS;OS;Treg;CD4+Th1, Th2, Th17;DC;

Countries

China

Contacts

Public ContactZhao Mingfeng

Department of Hematology, Tianjin First Center Hospital

mingfengzao@sina.com+86 13752640369

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 13, 2026