Clinical Study Protocol for Ultra-transplantation for the Treatment of Eastern Mediterranean Major

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 7
Maximum Age: 12
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Yunnan First People's Hospital
RECRUITING
Kunming
Contact Information
Primary
Yang tonghua T Yang, master
ynanblood@aliyun.com
86-13888555608
Time Frame
Start Date: 2025-08-29
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 5
Treatments
Experimental: Supergraft
Hypertransplantation is an innovative treatment plan of Professor Ai Huisheng's team, which uses hematopoietic stem cell transplantation from healthy donors who are haplotype compatible with the patient, and observes the patient's cell reinfusion response, hematopoietic reconstitution, hemoglobin level and blood transfusion, thalassemia clonal clearance, immune reconstitution, endocrine function recovery, gastrointestinal function recovery, as well as the incidence of graft-versus-host disease, infection and other complications after transplantation.
Sponsors
Leads: Hu Peng

This content was sourced from clinicaltrials.gov