Trials / Not Yet Recruiting
Not Yet RecruitingNCT06743113
Hypoxic Red Blood Cells in Sickle Cell Anemia
A Multi-Center, Randomized, Controlled, Cross-Over Study to Evaluate the Effectiveness of Hypoxic Red Blood Cells Processed With the Hemanext ONE® System Versus Conventional Red Blood Cells in Patients With Transfusion Dependent Sickle Cell Anemia
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- Sponsor
- Hemanext · Industry
- Sex
- All
- Age
- 7 Years
- Healthy volunteers
- Not accepted
Summary
The overall objective of this study is to evaluate the effectiveness and safety of transfusing hypoxic red blood cells manufactured with the Hemanext ONE system in patients with sickle cell anemia. The Hemanext ONE device was cleared through the De Novo process in September 2023.
Detailed description
In this Direct-to-Phase II study, Hemanext Inc. will carry out a prospective, multi-center, single-blind, randomized, cross-over study in patients with Sickle Cell Anemia, comparing the efficacy of transfusion of hypoxic red blood cells (HRBCs) to transfusions with conventional RBCs. The primary efficacy objective is to demonstrate an increase in %HbA between red cell exchange transfusions (RCE) of HRBCs compared to conventional RBCs. The increases in %HbA (normal Hb) from RCE will be accompanied by a concomitant decrease in sickle Hb (%HbS). The persistence of %HbA will allow for a decrease in the volume of RBCs transfused with an overall decrease in the number of units consumed, which in turn can result in an increase in time (number of days) between transfusions.
Conditions
- Sickle Cell Anaemia
- Sickle Cell Anemia Crisis
- Sickle Cell Anemia in Children
- Sickle Cell Anemia (HbSS, or HbSβ-thalassemia0)
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Hemanext ONE System | Hypoxic red blood cells |
| DEVICE | Conventional RBCs | Conventional red blood cells |
Timeline
- Start date
- 2026-03-01
- Primary completion
- 2028-04-01
- Completion
- 2028-09-01
- First posted
- 2024-12-19
- Last updated
- 2026-01-07
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06743113. Inclusion in this directory is not an endorsement.