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Clinical study of optimized Haplo-cord postposition mode with hematopoietic stem cell transplantation in children

Clinical study of optimized Haplo-cord postposition mode with hematopoietic stem cell transplantation in children

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037486
Enrollment
Unknown
Registered
2020-08-28
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-10-19

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

Conditions

pediatric hematopoietic stem cell transplantation

Interventions

Sponsors

Children's Hospital of Shanghai
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Aged 1 to 18 years; 2. Compliance with transplantation indications; 3. The guardian of the child has the desire and requirements for haploid hematopoietic stem cell transplantation, and sign the informed consent before treatment. The informed consent should inform all relevant contents of clinical research, and be willing to and abide by the treatment plan, follow-up plan, laboratory examination, etc.; 4. Before transplantation, blood routine examination, liver and kidney function, complete set of virus, HLA antibody screening, ECG, cardiac ultrasound, lung function, lung CT and other examinations were completed before transplantation, and the contraindications of transplantation were excluded; 5. allo-HSCT was not received before this transplantation; 6. Agreed to assist third party cord blood transfusion. Screening criteria for cord blood: 8 cord blood banks in China inquired about suitable cord blood, expanded the screening scope to find more satisfactory cord blood; eliminated DSA positive cord blood according to HLA antibody screening results; HLA matching was the priority factor, and HLA >=4/6 loci (HLA-A, B, drbl serological matching) were consistent among donors and recipients; the number of CD34 + in cord blood was more than 1x10^5/kg. The optimal selection sequence of cord blood was HLA matching > CD34+ number > blood type >gender resource.

Exclusion criteria

Exclusion criteria: 1. There are any contraindications to hematopoietic stem cell transplantation; 2. There are other serious diseases, such as serious damage of vital organs, respiratory failure, heart failure, liver insufficiency and renal insufficiency in decompensated period; 3. Other clinical researchers are in progress; 4. At the same time, suffering from other severe acute or chronic physiological or mental diseases, or abnormal laboratory examination, which may affect the patient's life safety and compliance, affect informed consent, research participation, follow-up or result interpretation; 5. They do not agree to assist the third-party cord blood transfusion or fail to screen qualified cord blood that meets the screening criteria.

Design outcomes

Primary

MeasureTime frame
Hematopoietic reconstitution;Immune reconstitution;

Secondary

MeasureTime frame
survival rate;complication;

Countries

China

Contacts

Public ContactKai Chen

Children's Hospital of Shanghai

chenk860622@163.com+86 13621904798

Outcome results

None listed

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