STEM CELL MOBILIZATION WITH HIGH-DOSE PLERIXAFOR IN PATIENTS WITH SICKLE CELL DISEASE
- Sponsor
- Hospital Israelita Albert Einstein
- Study ID
- NCT07341022
- Phase
- PHASE1/PHASE2
- Status
- Not Yet Recruiting
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Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 25 Years
- Healthy Volunteers
- Not accepted
Interventions
- Plerixafor Dose Escalation — DRUGPlerixafor will be administered as a single dose of 480 mcg/kg.
Study Details
The objective of this study is to demonstrate whether high-dose plerixafor can effectively mobilize hematopoietic stem cells in patients with sickle cell disease. It will also learn about the safety of this drug in higher doses in these patients. The main questions it aims to answer are: Does high-dose plerixafor mobilize enough hematopoietic stem cells? What medical problems do participants have when taking high-dose plerixafor? Participants will: Undergo transfusion Take high-dose plerixafor Be submitted to stem cell collection by apheresis Visit the clinic 10 days after the procedure Be contacted by the research team 30 days after the procedure.
Key Dates
- First listed
- Jan 14, 2026
- Start date
- Jun 1, 2026
- Status verified
- Dec 2025
- Primary completion
- Dec 31, 2027
- Completion
- Jun 30, 2028
Study Design
- Enrollment
- 12 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Arm A: high-dose plerixafor480 mcg/kg plerixafor
Primary Outcome Measure
CD34⁺ cell count [ Time Frame: 0 days ]
Central Contacts
- Karina Tozatto Maio, MD, PhD+551121511233
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