Ultra-transplantation (hypertransplantation) for major thalassemia
Official title: Clinical Study Protocol for Ultra-transplantation for the Treatment of Eastern Mediterranean Major
Run by The First People's Hospital of Yunnan · NCT06743477 · Data updated 2026-11-12
This project will try ultra-transplantation (hypertransplantation), a new stem-cell approach without pretreatment, in children aged 7–12 with severe thalassemia who cannot or decline standard stem cell or gene therapies.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 7 Years to 12 Years |
| Sex | All |
| Enrollment | 5 (estimated) |
| Sponsor | The First People's Hospital of Yunnan Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Kunming, Yunnan) |
| Status | Recruiting |
| Started | August 29, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | September 2, 2025 |
| Trial ID | NCT06743477 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 7–12 with severe thalassemia weighing under 40 kg who have available HLA-matched or mismatched donors and who cannot or refuse standard HSCT or gene therapy, and who provide informed consent, are the intended candidates.
✕Probably not a fit
Patients outside the 7–12 age range, those without any suitable donor, psychiatric patients, or those recently enrolled in other drug trials are unlikely to benefit or are excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers at Yunnan First People's Hospital will perform the 'Supergraft' ultra-transplantation, a hematopoietic stem-cell procedure designed to require no conditioning and to avoid graft‑versus‑host disease, building on promising animal data. Eligible children aged 7–12 with severe thalassemia and available HLA-matched or mismatched donors will be enrolled after informed consent and weight verification. The single-center intervention in Kunming will include donor screening, the Supergraft procedure, and follow-up to monitor safety, complications, and clinical outcomes such as transfusion independence. The trial seeks to determine whether this method is a safe and effective alternative to standard HSCT or lifelong transfusions.
Why it matters
Potential benefit: If successful, this approach could offer a simpler, lower‑risk curative transplant that reduces or ends lifelong blood transfusions for children with severe thalassemia.
How similar studies have gone: The hypertransplantation concept is novel in humans: animal experiments reported good efficacy, but clinical data in people are currently limited or lacking.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Yunnan First People's Hospital
Kunming, Yunnan, China Recruiting
Study contacts
- Principal investigator: Yang T Yang, master — The First People's Hospital of Yunnan
- Study coordinator: Yang tonghua T Yang, master
- Email: ynanblood@aliyun.com
- Phone: 86-13888555608
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.