Sickle Cell Disease Biofluid Chip Technology (SCD BioChip)
ConditionSickle Cell Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12+
SponsorUniversity Hospitals Cleveland Medical Center
About this trial
'Sickle-shaped' anemia was first clinically described in the US in 1910, and the mutated heritable sickle hemoglobin molecule was identified in 1949. The pathophysiology of SCD is a consequence of abnormal polymerization of sickle hemoglobin (HbS) and its effects on red cell membrane properties, shape, and density, and subsequent critical changes in inflammatory cell and endothelial cell function. Our goal is to understand the impact of CMA abnormalities in SCD, by interrogating a number of recognized interactions in a range of clinical phenotypes.
To date, correlative studies in SCD, by us and others, have range between clinical reports, based on tests, interventions, and chart review of individuals or groups of individuals and, at the other extreme, identification of functional gene polymorphisms based on population studies. The investigators wish to augment these studies through a systematic examination of cellular membrane properties and activation status. Of hematologic disorders, SCD may be unusually susceptible to such an examination.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male or female ≥12 years of age at the time of consent (enrollment).
Documentation Sickle Cell Disease, including HbSS or compound heterozygus HbSC- or HbSβ- thalassemia diagnosis as evidenced by one or more clinical features.
Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
Disqualifiers
Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
Trial population
Children (≥12 years old) and adults with SCD, including HbSS or compound heterozygus HbSC- or HbSβ- thalassemia will be offered participation. Control samples (HbAA) may be obtained from healthy volunteers.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
SCD Group
Other interventionNo Intervention. Use of discard blood/tissue
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Minor SCD Group, Ages 12-171 intervention
Group B: Adult SCD. Ages 18+1 intervention
Trial outcomes
Primary outcomes
1
Develop an SCD Biochip with which to examine key cellular properties and interactions, including RBC and WBC cellular, adhesive, and inflammatory properties, and circulating endothelial and hematopoietic precursor cell characteristics.
Red and white cell adhesion to biomolecules (e.g. laminin, fibronectin, and selectins) will be measured on a microfluidic device, the SCD Biochip. Adhesion will be measured under normal oxygen and low oxygen conditions. Adhesions will be assessed relative to clinical findings, such as hematology parameters, and evidence for vaso-occlusion, pain, inflammation, and vasculopathy in patients with sickle cell disease.endothelial and hematopoietic precursor cells based on membrane properties and adhesion.
Time frame
2 yearsSecondary outcomes
1
Correlate SCD Biochip function in heterogeneous SCD populations, including HbSS and HbSC at a range of ages, and in those with acute and chronic complications and compared with normal controls.
The investigators will examine and validate clinical correlations with these cellular/membrane properties in larger populations of SCD, across a range of phenotypes, using our simple rapid flexible SCD Biochip platform.
Time frame
2 yearsSponsors and contacts
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University Hospitals Cleveland Medical Center
Lead sponsor
Case Western Reserve University
Collaborator
Source ClinicalTrials.gov