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Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives

Use of Granulocyte Colony Stimulating Factor (G-CSF) Mobilized Leukapheresis Collections From Healthy Volunteers to Develop Improved Methods of Stem Cell and Lymphocyte Selection for Allogeneic Transplantation

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 60 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests better ways to prepare donated blood stem cells for transplant by removing white blood cells that can attack the patient’s body. It also studies how G-CSF, a drug that helps make more stem cells, affects these white blood cells. The study is for healthy volunteers ages 18 to 60.

Bone marrow transplants (BMT) are one form of treatment for disorders of the blood, including leukemia. However, because the procedure is often associated with potentially life-threatening reactions, it is usually reserved for patients with serious illnesses under the age of 60 years old. One serious reaction complicating bone marrow transplants is referred to as graft-versus-host disease (GVHD). GVHD is a potentially fatal incompatibility reaction. The reaction is caused by antigens found on the cells of the patient that are not present on the cells of the donor. The antigens are recognized by transplanted white blood cells (lymphocytes). These lymphocytes begin attacking the recipient s cells and tissues and may lead to death. In order to avoid GVHD, researchers have developed a technique using peripheral blood instead of bone marrow that allows transplantation of stem cells and removal of lymphocytes. Stem cells are the cells responsible for returning blood cell production to normal. Lymphocytes are the white blood cells that can cause GVHD. The technique requires two steps. In the first step blood cells are collected from donors who have received doses of a growth factor. The growth factor (granulocyte colony stimulating factor) is designed to increase the production of donor stem cells. In the second step white blood cell lymphocytes are removed from the collected blood, leaving only the stem cells. The main goal of this study is to develop and improve the method of processing cells that are collected after stimulation with growth factor (G-CSF), by removing the white blood cell lymphocytes which can cause graft-versus-host disease (GVHD) while keeping the stem cells necessary for healthy blood cell building. In addition, researchers are interested in studying whether giving G-CSF has an effect on lymphocyte function, which may influence the immune reactions occurring in bone marrow transplantation.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be healthy and 18 to 60 years old.
  • Have no current infection or history of repeated infections.
  • Have normal kidney, liver, and blood test results that meet the study’s limits.
  • Have normal heart and blood vessel health, with no history of chest pain, heart attack, poor blood flow in the limbs, mini-stroke, or stroke.
  • If able to become pregnant, have a negative blood pregnancy test within one week of starting G-CSF. Do not be breastfeeding.
  • Qualify to donate blood and test negative for all required infections, including syphilis, hepatitis B and C, HIV, HTLV-1, West Nile virus, T. cruzi, and Babesia.
  • Understand that this is a research study and agree to take part.
  • Have veins near the elbow suitable for apheresis, a process that collects cells from blood. A nurse must check the veins before enrollment.

Who can't join

  • Have a current infection or a positive result on any required infection screening test.
  • Be pregnant or breastfeeding.
  • Have an active or moderate-to-severe autoimmune disease, where the immune system attacks the body, that needs or is expected to need drugs that weaken the immune system. Mild, well-controlled disease may be considered.
  • Have current cancer or cancer within the past 5 years. Some low-risk cancers in remission for more than 5 years, or treated basal cell skin cancer, may be allowed.
  • Have any history of blood disorders, or serious heart or blood vessel disease. Minor risks, such as controlled high blood pressure, are reviewed case by case.
  • Be allergic to G-CSF or products made from E. coli bacteria.
  • Have taken an NSAID, an anti-inflammatory pain medicine, within 5 to 7 days before starting the study. The timing depends on the drug.
  • Have received G-CSF and had leukapheresis, a procedure to collect white blood cells, within the past 3 months.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

* INCLUSION CRITERIA: * Healthy individual aged 18 to 60 years. * No active infection or history of recurrent infection. * Normal renal function: creatinine \<1.5 mg/dL or estimated glomerular filtration rate (eGFR) \>=60 mL/min/1.73 m\^2, with no significant proteinuria. Normal liver function: bilirubin \<2.0 mg/dL (when unconjugated), transaminases \<2.0x ULN in the absence of known liver disease. Normal blood count: WBC 2,500-11,000/microliter, ANC \>1,500/microliter, platelets \>150,000/microliter, hemoglobin \>12.0 g/dL. * Normal cardiovascular function, no history of chest pain, myocardial infarction, peripheral vascular disease, transient ischemic attack, or stroke. * Healthy female subjects of childbearing age should have a negative serum pregnancy test with one week of beginning G-CSF administration. * Female subjects should not be lactating. * Subject must be eligible for normal blood donation. He or she must be tested negative for syphilis (RPR), hepatitis B and C (HBsAg, Anti-HBc, Anti-HCV), HIV, HTLV-1, West Nile virus, T. Cruzi and Babesia test. * Subject must be able to comprehend the investigational nature of the study and provide informed consent to participate in the protocol. * Antecubital veins must be adequate for peripheral access during apheresis. Potential participants must be screened by an apheresis nurse to check venous access before protocol entry. EXCLUSION CRITERIA: * Active viral, bacterial, fungal or parasite infection. * Female with positive pregnancy test or lactating. * Active or moderate-to-severe autoimmune disease that is currently treated or expected to require immunosuppressive therapy. Candidates with stable, well-controlled mild autoimmune disease may be considered on a case-by-case basis. * Active or recent malignancy within the past 5 years. Individuals with remote (\>5 years) histories of low-risk malignancies in remission (e.g., localized prostate cancer) or treated basal cell carcinoma may be included. * History of any hematologic disorders. * History of clinically significant cardiovascular disease (e.g., symptomatic coronary artery disease, uncontrolled hypertension). Minor risk factors must be evaluated on a case-by-case basis (e.g., controlled hypertension). * Any positive serum screening test as listed in eligibility. * Allergy to G-CSF or bacterial E coli products. * Administration of NSAID within. 5-7 days of starting the protocol, depending on drug half-life. * History of G-CSF administration and leukapheresis within past 3 months.

Study sites (1)

MD