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NCT06287086Not yet recruiting

Clinical Study on the Safety and Efficacy of BRL-101 in the Treatment of Sickle Cell Disease

Clinical Study on the Safety and Efficacy of a Single Intravenous Dose of CRISPR/Cas9-Edited Autologous CD34+ Hematopoietic Stem/Progenitor Cells (BRL-101) in the Treatment of Sickle Cell Disease
Bioray LaboratoriesClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Sickle Cell Disease
Drug/Device/Intervention
BRL-101 autologous hematopoietic stem and progenitor cells injection
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Bioray Laboratories
Timeline & enrollment
Phase
N/A
Start date
May 14, 2024
End date
Jun 10, 2026
Enrollment
1 participants
Primary outcome

Proportion of stem cell engrafted subjects,Time to neutrophil engraftment,Frequency, severity, and relationship to BRL-101 of adverse events over 12 months following BRL-101 infusion..

Summary

This is a single center, non-randomized, open label, single-dose study in subjects with
 Sickle Cell Disease (SCD). The study will evaluate the safety and efficacy of autologous
 CRISPR-Cas9 modified CD34+ human hematopoietic stem and progenitor cells (hHSPCs) (BRL-101)

ICD-10 classifications
Sickle-cell disordersOther sickle-cell disordersSickle-cell traitSickle-cell anaemia with crisisSickle-cell anaemia without crisis
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06287086
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06287086 through Pure Global AI's free database. This phase not specified trial is sponsored by Bioray Laboratories and is currently Not yet recruiting. The study focuses on Sickle Cell Disease. Target enrollment is 1 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.