At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 4 enrolled
Drug / intervention
βAS3-FB vector transduced peripheral blood CD34+ cellsbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Clinical Research Study of Autologous Stem Cell Transplantation for Sickle Cell Disease (SCD) Using Peripheral Blood CD34+ Cells Modified With the Lenti/G-βAS3-FB Lentiviral Vector
In Brief
A Phase 2 clinical trial evaluating βAS3-FB vector transduced peripheral blood CD34+ cells for Sickle Cell Disease. Completed, enrolled 4 participants across 1 site.
Detailed Summary
This Phase I clinical trial will assess the safety and initial evidence for efficacy of an autologous transplant of lentiviral vector modified peripheral blood for adults with severe sickle cell disease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSickle Cell Disease
CountriesUnited States
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 2014
Enrollment StartDec 2014
Primary CompletionSep 2025
TodayJul 2026
First PostedSep 25, 2014
Enrollment StartDec 1, 2014
Primary CompletionSep 24, 2025
TodayJul 2, 2026
Enrollment to primary: 10.8 yearsPosted 11.8 years ago
Interventions
βAS3-FB vector transduced peripheral blood CD34+ cellsbiological
CD34+ from the peripheral blood of patients with sickle cell disease (SCD) are transduced ex-vivo with the Lenti/βAS3-FB lentiviral vector. The transduced cells are then infused into the patient.