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Hypoxic Red Blood Cells in Sickle Cell Anemia

N/A
Waitlist Available
Led By Enrico Novelli, MD, MS
Research Sponsored by Hemanext
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
1. Male or female at least 7 years of age;
2. Are able to provide informed consent, and assent as applicable, to participate in the study;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 14 months
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Sickle Cell Anemia
  • Sickle Cell Disease
  • Sickle Cell Crisis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 14 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 14 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
%HbA Rate of Decline
Secondary study objectives
Change in QoL
Changes in hepatic iron content
Duration (days) of any hospitalization for vaso-occlusive crisis
+10 more
Other study objectives
Hemoglobin increment from each transfusion

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment A (Hypoxic RBCs)Experimental Treatment1 Intervention
Transfusion of hypoxic red blood cells manufactured with Hemanext ONE system
Group II: Treatment B (Conventional RBCs)Active Control1 Intervention
Transfusion of conventional red blood cells

Find a Location

Who is running the clinical trial?

University of ConnecticutOTHER
192 Previous Clinical Trials
160,832 Total Patients Enrolled
1 Trials studying Sickle Cell Anemia
200 Patients Enrolled for Sickle Cell Anemia
University of Pittsburgh Medical CenterOTHER
75 Previous Clinical Trials
76,895 Total Patients Enrolled
Johns Hopkins All Children's HospitalOTHER
46 Previous Clinical Trials
5,008,436 Total Patients Enrolled
Johns Hopkins UniversityOTHER
2,339 Previous Clinical Trials
14,881,738 Total Patients Enrolled
2 Trials studying Sickle Cell Anemia
100 Patients Enrolled for Sickle Cell Anemia
HemanextLead Sponsor
4 Previous Clinical Trials
144 Total Patients Enrolled
Emory UniversityOTHER
1,708 Previous Clinical Trials
2,607,450 Total Patients Enrolled
1 Trials studying Sickle Cell Anemia
134 Patients Enrolled for Sickle Cell Anemia
Enrico Novelli, MD, MSPrincipal InvestigatorUniversity of Pittsburgh Medical Center
1 Previous Clinical Trials
20 Total Patients Enrolled
Biree Andemariam, MDPrincipal InvestigatorNew England Sickle Cell Institute, University of Connecticut
Laurel Omert, MD, FACSPrincipal InvestigatorHemanext Inc.
~32 spots leftby Feb 2028
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