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NCT05864170
the Safety and Efficacy Evaluation of HGI-001 Injection in Patients With Transfusion-Dependent β-Thalassemia
EARLY_PHASE1 trial testing β-globin restored autologous hematopoietic stem cells in β-thalassemia in 3 participants. Currently enrolling.
30 December 2025
Quick facts
| Lead sponsor | Shenzhen Hemogen |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 3 |
| Start date | 27 May 2022 |
| Primary completion | 30 December 2025 |
| Estimated completion | 30 December 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- β-globin restored autologous hematopoietic stem cells
Conditions studied
- β-thalassemia — all drugs for β-thalassemia →
Sponsor
Shenzhen Hemogen — full company profile →
Who can join
Adults 18 to 35, any sex, with β-thalassemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is an open label study to evaluate the safety and efficacy of β-globin Restored Autologous Hematopoietic Stem Cells in ß-Thalassemia Major Patients
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05864170
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of β-globin restored autologous hematopoietic stem cells
Trials testing the same drug.
- NCT06655662 — Evaluating Safety and Efficacy of Lentiviral-transduced CD34+ HSCs in Β-thalassaemia Patients. · Phase 1 · recruiting
- NCT05745532 — Safety and Efficacy Evaluation of β-globin Restored Autologous Hematopoietic Stem Cells in β-thalassemia Major Patients · EARLY_PHASE1 · recruiting
Other recruiting trials for β-thalassemia
Currently open trials in the same condition.
- NCT07215975 — A Real-World Study to Evaluate Luspatercept in Adults With Transfusion-Dependent Beta-Thalassemia in the Middle East · recruiting
- NCT05745532 — Safety and Efficacy Evaluation of β-globin Restored Autologous Hematopoietic Stem Cells in β-thalassemia Major Patients · EARLY_PHASE1 · recruiting
Other Shenzhen Hemogen trials
Trials by the same sponsor.
- NCT06655662 — Evaluating Safety and Efficacy of Lentiviral-transduced CD34+ HSCs in Β-thalassaemia Patients. · Phase 1 · recruiting
- NCT05851105 — the Safety and Efficacy Evaluation of HGI-002 Injection in Patients With Transfusion-Dependent α-Thalassemia · EARLY_PHASE1 · recruiting
- NCT05745532 — Safety and Efficacy Evaluation of β-globin Restored Autologous Hematopoietic Stem Cells in β-thalassemia Major Patients · EARLY_PHASE1 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05864170 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shenzhen Hemogen
- Last refreshed: 29 November 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05864170.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing