A Trial to Assess Haploidentical T-depleted Stem Cell Transplantation in Patients With SCD
NCT04201210 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 212
Last updated 2024-05-13
Summary
HSCT is currently the only curative option for SCD but less than 20% of SCD patients have a MD donor available. So far, all curative approaches beyond a MSD HSCT at young age are non-satisfactory. With the lack of a suitable donor for the vast majority of patients, the major question of this trial is, if a haploidentical αß/CD19+ T-cell depleted HSCT can be a valid alternative to a MSD HSCT. The main challenge in non-malignant diseases is to offer a safe and GvHD-free HSCT without rejection.
Conditions
- HbS Disease
- Hemoglobin S Disease
- Sickle Cell Anemia
- Sickle Cell Disorders
- Sickling Disorder Due to Hemoglobin S
- Sickle Cell Disease
Interventions
- OTHER
-
TCRα/β+ and CD19+ depleted haploidentical stem cell transplantation
Haploidentical 5+/10 HSCT from a relative, α/β T-depleted
- OTHER
-
Matched sibling donor transplantation
10/10 HSCT - matched family donor
Sponsors & Collaborators
-
University of Regensburg
lead OTHER
Principal Investigators
-
Selim Corbacioglu, MD · University Hospital of Regensburg
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 2 Years
- Max Age
- 35 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-06-30
- Primary Completion
- 2028-03-31
- Completion
- 2030-03-31
Countries
- Austria
- Germany
Study Locations
More Related Trials
-
HSCT For Patients With High Risk Hemoglobinopathies Using Reduced Intensity
NCT02435901 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Stem Cell Transplantation for Sickle Cell Anemia
NCT01877837 ·Status: COMPLETED ·Phase: PHASE3
-
HLA Haploidentical Bone Marrow Transplant in Patients With Severe Sickle Cell Disease
NCT03240731 ·Status: COMPLETED ·Phase: PHASE2
-
Phase I/II Pilot Study of Mixed Chimerism to Treat Hemoglobinopathies
NCT00777231 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Blood Stem Cell Transplant for Sickle Cell Disease
NCT03249831 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Unrelated Umbilical Cord Blood Following HLA-haploidentical Hematopoietic Stem Cell Transplantation in Patients With β-thalassemia Major
NCT02126046 ·Status: UNKNOWN ·Phase: NA
-
Allo-HCT MUD for Non-malignant Red Blood Cell (RBC) Disorders: Sickle Cell, Thal, and DBA: Reduced Intensity Conditioning, Co-tx MSCs
NCT00957931 ·Status: COMPLETED ·Phase: PHASE2
-
Phase I/II Pilot Study of Mixed Chimerism to Treat Hemoglobinopathies
NCT01419704 ·Status: WITHDRAWN ·Phase: PHASE1/PHASE2
-
Hematopoietic Stem Cell Transplant for Sickle Cell Disease
NCT02065596 ·Status: COMPLETED ·Phase: PHASE1
-
Allograft for Sickle Cell Disease and Thalassemia
NCT02038478 ·Status: WITHDRAWN ·Phase: PHASE2
-
Hematopoietic Stem Cell Transplantation for Patients With Thalassemia Major: A Multicenter, Prospective Clinical Study
NCT04009525 ·Status: COMPLETED ·Phase: PHASE4
-
HLA-Identical Sibling Donor Bone Marrow Transplantation for Individuals With Severe Sickle Cell Disease Using a Reduced Intensity Conditioning Regimen
NCT02776202 ·Status: UNKNOWN ·Phase: PHASE2
-
Sickle Cell Disease and CardiovAscular Risk - Red Cell Exchange Trial (SCD-CARRE)
NCT04084080 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
US Phase I Study of ECT-001-CB in Patients With Sickle-Cell Disease
NCT04594031 ·Status: WITHDRAWN ·Phase: PHASE1
-
Vitamin D and Bisphosphonates in the Treatment of Sickle Cell Disease
NCT02972138 ·Status: COMPLETED
-
Methadone in Pediatric and Adult Sickle Cell Patients
NCT00761085 ·Status: COMPLETED ·Phase: NA
-
Repeat Peripheral Blood Stem Cell Transplantation for Patients With Sickle Cell Disease and Falling Donor Myeloid Chimerism Levels
NCT04008368 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
A Phase I/II Trial of Recombinant-Methionyl Human Stem Cell Factor (SCF) in Adult Patients With Sickling Disorders
NCT00005783 ·Status: COMPLETED ·Phase: PHASE1
-
In Utero Hematopoietic Stem Cell Transplantation for Alpha-thalassemia Major (ATM)
NCT02986698 ·Status: TERMINATED ·Phase: PHASE1
-
Phase I/II Randomized Study of Hydroxyurea With or Without Clotrimazole in Patients With Sickle Cell Anemia
NCT00004492 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Induction of Stable Chimerism for Sickle Cell Anemia
NCT00029393 ·Status: COMPLETED ·Phase: PHASE2
-
SCD Stem Cell Mobilization and Apheresis Using Motixafortide
NCT06442761 ·Status: RECRUITING ·Phase: PHASE1
-
A Study to Evaluate GBT021601-012 Single Dose and Multiple Dose in Participants With Sickle Cell Disease (SCD)
NCT04983264 ·Status: COMPLETED ·Phase: PHASE1
-
A Study Evaluating the Safety and Efficacy of Lovo-cel in Severe Sickle Cell Disease
NCT02140554 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
RH Genotype Matched RBC Transfusions
NCT04156893 ·Status: RECRUITING ·Phase: PHASE1/PHASE2