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NCT Number: NCT02824471

Sickle Cell Disease Biofluid Chip Technology (SCD BioChip)

'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.

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Novel biofluidic chip technology can investigate surface characteristics that are typically measured with conventional techniques, such as fluorescent activated cell sorting (FACS), immunohistochemistry, or microscopic imaging methods. In FACS, cells of interest are isolated, extensively processed, incubated with a fluorescent-labeled antibody and sorted by optical recognition. In the proposed SCD biofluidic chip (SCD biochip), the interrogating antibody coats the microchannel surface and captures the cell population(s) of interest, without processing, incubation, or in vitro manipulation. The SCD biochip can also quantitate cellular adherence to experimental biological surfaces that are comprised of subcellular components. The SCD biochip is technically simple and experimentally flexible, whereby the population of interest is retained on the chip and quantitated in situ. The microchip system allows retrieval of viable isolated cells for potential downstream processing, analysis, and in vitro culture.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

SCD Group

Other

No Intervention. Use of discard blood/tissue

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.

    Time frame: 2 years

    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.

Secondary 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.

    Time frame: 2 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Umut Gurkan, PhD

CONTACT

[email protected]

(216) 368-6447

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Collaborators

  • Case Western Reserve University

Registry information

Official study title

Sickle Cell Disease (SCD) Biochip': Towards a Simple and Reliable Way to Monitor Sickle Cell Disease

Important dates

Study start
2014
Primary completion
2028
Study completion
2028
First posted
Jul 6, 2016
Registry last updated
Aug 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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