Improved methods for selecting cells in bone marrow transplants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study focuses on enhancing the safety and effectiveness of allogeneic bone marrow transplants by exploring new techniques for cell selection. Researchers aim to use peripheral blood stem cells (PBSC) collected from healthy donors, utilizing G-CSF to mobilize these cells. The study will analyze the collected samples to develop methods that can reduce the risk of graft-versus-host disease (GVHD) while preserving the donor's immune function. By testing various purification approaches, the research seeks to improve transplantation outcomes for patients with blood disorders.

Why it matters

Who can join: the full rules

* 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.

Where it's running

• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting

Study contacts

• Principal investigator: Andre Larochelle, M.D. — National Heart, Lung, and Blood Institute (NHLBI)
• Study coordinator: Richard A Gustafson, R.N.
• Email: richard.gustafson@nih.gov
• Phone: (301) 402-5822

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using Ruxolitinib to prevent complications after haploidentical stem cell transplants

  This study is testing if the drug Ruxolitinib can help prevent complications like graft-versus-host disease in patients receiving stem cell transplants from partially matched donors.

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• Anti-CD25 antibody to prevent acute GVHD after haploidentical stem cell transplant

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• Ruxolitinib for Graft-Versus-Host Disease in Clinical Practice

  This study tests how well Jakavi (ruxolitinib) works and how safe it is for people with acute or chronic GVHD being treated in real-world medical settings.

  Recruiting Novartis · Tokyo · NCT07594587

• Moxibustion with second-line treatment for steroid-refractory acute graft-versus-host disease after transplant

  This study will test whether adding moxibustion to standard second-line drug therapy helps people aged 14–65 with steroid-refractory gastrointestinal acute GVHD after an allogeneic stem cell transplant.

  Recruiting Phase 2 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Wuhan, Hubei · NCT07572669

• Cord blood transplant for children and young adults with blood cancers.

  This study will test whether a cord blood transplant given as a first or second transplant can help children and young adults with leukemia, myelodysplasia, or lymphoma who lack a matched donor.

  Recruiting Phase 2 Memorial Sloan Kettering Cancer Center · New York, New York · NCT07566377

• Ruxolitinib maintenance after stem cell transplant for T‑cell lymphoma

  This phase II trial tests whether taking ruxolitinib after a stem cell transplant can lower the chance of relapse and graft‑versus‑host disease for people treated for T‑cell lymphoma.

  Recruiting at 2 sites Phase 2 Ohio State University Comprehensive Cancer Center · Columbus, Ohio and 1 other locations · NCT07356245

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.