Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2025-12-25 @ 12:19 AM
NCT ID:
NCT05066958
Eligibility Criteria:
Inclusion Criteria:
1. Informed consent signed by the patient (ages 14 to 18) and / or his legal representative (ages 0 to 18).
2. The patient has an indication for allogeneic transplantation of hematopoietic stem cells established in accordance with the current regulatory framework
3. Planned HSCT selective immunomagnetic depletion of alpha/betta T lymphocytes
4. Karnovsky or Lansky index more than 50%
5. Life expectancy at least 4 weeks
6. Heart function: ejection fraction of at least 40%
7. Consent to continue follow-up for 5 years
Exclusion Criteria:
1. Acute viral hepatitis or acute HIV infection
2. Hypoxemia with SaO2 \<90%
3. Bilirubin\> 3 norms
4. Creatinine\> 3 norms
5. Pregnancy and lactation
6. Severe uncontrolled infection
7. Severe (\>?) pathology of the central nervous system (epilepsy, dementia, organic damage to the central nervous system, psychosis)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Month
Maximum Age:
18 Years
Study:
NCT05066958
Study Brief:
Protocol Section:
NCT05066958