Actively Recruiting

Age: 18Years - 70Years
All Genders
Healthy Volunteers
ID00001405

Recruitment and Apheresis Collection of Peripheral Blood Hematopoietic Stem Cells, Mononuclear Cells and Granulocytes

Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-06-03

850

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to collect CD34+ hematopoietic stem cells (HSC), mononuclear cells, and granulocytes from peripheral blood and bone marrow of adults. These cells will be used in laboratory studies and clinical treatments to develop new cell therapies for patients with inherited or acquired immune or blood disorders. Both healthy adult volunteers and adult patients with primary immune deficiencies or blood disorders may participate to support research and clinical therapy development. Most participants will undergo daily injections of granulocyte colony stimulating factor (G-CSF) for 5 to 6 days to help move HSC into the blood, followed by apheresis collection. Some patients may have bone marrow collected through aspiration or harvesting for clinical or research use. Mononuclear cells and granulocytes may be collected from blood with or without pre-treatment using G-CSF and dexamethasone. Collected cells are used for gene therapy development, cell engineering, and laboratory studies to understand disease mechanisms and improve treatments. Participants will be involved in cell collection procedures such as apheresis or bone marrow aspiration. Researchers will monitor cell mobilization and collection success, perform laboratory studies on the collected cells, and store samples for future research or clinical use. The study tracks outcomes including cell mobilization, collection, and laboratory research results. Participants may contribute to ongoing development of gene therapies or cellular treatments under separate approved protocols.

CONDITIONS

Brief Title

Recruitment and Apheresis Collection of Peripheral Blood Hematopoietic Stem Cells, Mononuclear Cells and Granulocytes

Who Can Participate

Age: 18Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 to 70 with a genetically defined primary immune deficiency or blood disorder or clinical history consistent with these conditions
  • Adult healthy volunteers aged 18 to 65 without active infections or history of recurrent infections
  • Patients with preserved kidney, liver, and blood function as specified by lab values
  • Patients and healthy volunteers of childbearing potential using effective contraception and with negative pregnancy tests
  • Willingness to allow blood cell samples to be stored and modified for research
  • Healthy volunteers must weigh at least 50 kg
Not Eligible

You will not qualify if you...

  • Patients who are hemodynamically unstable or require mechanical respiratory support
  • Pregnant or lactating females
  • Patients or volunteers with active bacterial, fungal, or viral infection
  • Positive results on routine blood donor eligibility tests for infectious diseases (exceptions apply for certain patient groups)
  • Healthy volunteers without adequate peripheral venous access for apheresis
  • Patients unable to lie prone or tolerate general anesthesia for bone marrow harvesting
  • Participation deemed by investigator to pose undue risk to healthy volunteers

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Sample Collection

Duration - Up to 6 days depending on mobilization and collection procedures

Participants undergo collection of hematopoietic stem cells, mononuclear cells, and granulocytes from peripheral blood and/or bone marrow for laboratory research and/or clinical use under separate protocols.

Daily visits for up to 6 days for subcutaneous injections and apheresis collections

Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

J

Joanna L Peterson

H

Harry L Malech, M.D.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

Granulocyte colony-stimulating factor recruitment of CD34+ progenitors to peripheral blood: impaired mobilization in chronic granulomatous disease and adenosine deaminase--deficient severe combined immunodeficiency disease patients.

S Sekhsaria, T A Fleisher, S Vowells...

https://pubmed.ncbi.nlm.nih.gov/8704221

CD34+ peripheral blood progenitors as a target for genetic correction of the two flavocytochrome b558 defective forms of chronic granulomatous disease.

F Li, G F Linton, S Sekhsaria...

https://pubmed.ncbi.nlm.nih.gov/7517218

Prolonged production of NADPH oxidase-corrected granulocytes after gene therapy of chronic granulomatous disease.

H L Malech, P B Maples, N Whiting-Theobald...

https://pubmed.ncbi.nlm.nih.gov/9342375