NCT06743477Recruiting
A Clinical Study of Ultra-transplantation for the Treatment of Major Thalassemia Scheme
Clinical Study Protocol for Ultra-transplantation for the Treatment of Eastern Mediterranean Major
Source: ClinicalTrials.gov · Last updated 2 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Yunnan is a high-incidence area of Eastern Mediterranean (thalassemia) in China, and the treatment cost of thalassemia patients is high, hematopoietic stem cell transplantation (HSCT) is the only means to cure thalassemia, but there are problems in donor screening and the risk of complications. Professor Ai Huisheng's team proposed a new concept of hypertransplantation, which does not require pretreatment and has no risk of GVHD, and animal experiments have shown good efficacy. Under the guidance of Professor Ai, the center plans to carry out clinical research on hypertransplantation and explore safe and effective new therapies for thalassemia.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 5 (estimated)
- First submitted
- 24 Nov 2024
- Start date
- 29 Aug 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Hu Peng
- Diseases
- Thalassaemia
- NCT number
- NCT06743477
What you commit to
- Study type: Interventional
- Planned participants: 5
- From 29 Aug 2025 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Patient inclusion criteria :
- Diagnosed with severe Mediterranean anemia, with no restrictions on alpha and beta types;
- Age between 7-12 years old, male or female not limited; Weight\<40kg
- The patient has or does not have HLA matched or semi matched donors, but unconditionally transplants or refuses to undergo blood stem cell transplantation treatment; And patients who unconditionally or refuse to undergo gene therapy for thalassemia;
- There are HLA matched or mismatched donors who meet the donor criteria through physical examination;
- The patient and their family agree to receive super transplantation treatment and sign a written informed consent form before the transplantation trial.
- （2） Exclusion criteria for patients:
- Psychiatric patients;
- Participants in clinical trials of other drugs within the past month;
- There are no suitable HLA mismatched donors available.
- Other researchers have determined that they are not suitable to participate in this study.
- （3） Supplier screening criteria:
- HLA typing matches the patient's haplotype
- KIR configuration
- NIMA
- DSA negative
- Routine physical examination
- Genetic screening for carriers of thalassemia, mild or no carriers of thalassemia
- Sign the informed consent form.
Age in the registry: 7 years to 12 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yunnan First People's Hospital Coordinator of this site? Confirm its status | Kunming | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.