← Back to Search

Hematopoietic Stem Cell Transplantation

Filgrastim-Mobilized Stem Cell Collection for Healthy Donors

Phase 3
Recruiting
Led By John P Miller, MD, PhD
Research Sponsored by Center for International Blood and Marrow Transplant Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up ongoing
Awards & highlights

Study Summary

This trial is looking at how safe and effective it is to collect stem cells from donors who are given filgrastim, a medication that helps increase the number of stem cells in the blood.

Who is the study for?
This trial is for healthy individuals eligible to donate stem cells, similar to marrow donors. They must not be pregnant or breastfeeding without interruption, have no history of certain eye conditions (iritis/episcleritis), low platelet counts, sickle cell trait, lithium treatment, sensitivity to filgrastim or E. coli proteins, autoimmune disorders unless successfully treated thyroid disease, and no deep vein thrombosis or pulmonary embolism.Check my eligibility
What is being tested?
The study tests a system for collecting stem cells from unrelated donors using a drug called filgrastim. It looks at the safety of this drug and procedure in donors and how well these collected stem cells work in transplant recipients needing new blood-forming cells.See study design
What are the potential side effects?
Potential side effects include bone pain due to high white blood cell release stimulated by filgrastim and possible reactions related to the collection process like dizziness or lightheadedness during leukapheresis (the procedure used to collect white blood cells).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~ongoing
This trial's timeline: 3 weeks for screening, Varies for treatment, and ongoing for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Establish and evaluate a system for collection of filgrastim-mobilized peripheral blood stem cells from NMDP donors.
Secondary outcome measures
Assess the safety among NMDP donors of filgrastim administration and PBSC leukapheresis
Assess the safety and efficacy of filgrastim-mobilized PBSC in unrelated donor hematopoietic stem cell transplant recipients
Determine the acceptability of stem cell donation by filgrastim stimulated apheresis in normal donors

Find a Location

Who is running the clinical trial?

National Marrow Donor ProgramOTHER
60 Previous Clinical Trials
142,560 Total Patients Enrolled
Center for International Blood and Marrow Transplant ResearchLead Sponsor
38 Previous Clinical Trials
200,133,430 Total Patients Enrolled
John P Miller, MD, PhDPrincipal InvestigatorNational Marrow Donor Program
1 Previous Clinical Trials
21,974 Total Patients Enrolled

Media Library

Filgrastim-Mobilized Stem Cells (Hematopoietic Stem Cell Transplantation) Clinical Trial Eligibility Overview. Trial Name: NCT00785525 — Phase 3
Healthy Subjects Research Study Groups:
Healthy Subjects Clinical Trial 2023: Filgrastim-Mobilized Stem Cells Highlights & Side Effects. Trial Name: NCT00785525 — Phase 3
Filgrastim-Mobilized Stem Cells (Hematopoietic Stem Cell Transplantation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00785525 — Phase 3
Healthy Subjects Patient Testimony for trial: Trial Name: NCT00785525 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open slots in this research project for willing test subjects?

"From what is detailed on clinicaltrials.gov, it appears as if this trial is still searching for participants. The study was originally posted on February 1st 1997 and was most recently updated on March 7th 2022."

Answered by AI

If I qualify, may I enroll in this research study?

"This trial is for healthy individuals aged 18-60. There are around 40000 slots available for participants."

Answered by AI

How many test subjects are part of this experiment?

"This study requires 40000 participants that meet the pre-specified inclusion criteria. Potential enrollees can be based out of various locations, such as LifeStream in San Bernardino, California and City of Hope National Medical Center in Duarte, New york."

Answered by AI

Can senior citizens participate in this research?

"Eligibility requirements for this study include being between 18-60 years old."

Answered by AI

Could you elaborate on the risks associated with this treatment?

"The safety of this intervention falls on a spectrum from 1 to 3. Our team has given it a 3 because Phase 3 trials have both some evidence of efficacy and multiple rounds data supporting safety."

Answered by AI

Across how many hospitals is this trial being conducted?

"There are a total of 20 available clinical trial sites for this treatment, including locations such as LifeStream in San Bernardino, City of Hope National Medical Center in Duarte, and DKMS Americas in New york."

Answered by AI

Who else is applying?

What state do they live in?
Wisconsin
New York
Texas
Other
How old are they?
18 - 65
What site did they apply to?
Dana Farber/Partners Cancer Care
Rhode Island Blood Center
GenCure Cellular Therapy Center
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
0

Why did patients apply to this trial?

I need money. Believe in modern science. First try to see if I can get into a trial.
PatientReceived 1 prior treatment
I am interested in what the findings will be. I am a healthy person who wishes to help people.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

How dangerous is this?
PatientReceived 2+ prior treatments

How responsive is this trial?

Most responsive sites:
  1. Dana Farber/Partners Cancer Care: < 48 hours
  2. Gulf Coast Regional Blood Center: < 48 hours
  3. GenCure Cellular Therapy Center: < 48 hours
Typically responds via
Email
Average response time
  • < 2 Days
Recent research and studies
BloodJournal
Donor, Recipient, and Transplant Characteristics as Risk Factors After Unrelated Donor PBSC Transplantation: Beneficial Effects of Higher CD34+ Cell Dose
Pulsipher, Michael A., Pintip Chitphakdithai, Brent R. Logan, Susan F. Leitman, Paolo Anderlini, John P. Klein, Mary M. Horowitz, John P. Miller, Roberta J. King, and Dennis L. Confer. 2009. “Donor, Recipient, and Transplant Characteristics as Risk Factors After Unrelated Donor PBSC Transplantation: Beneficial Effects of Higher CD34+ Cell Dose”. Blood. American Society of Hematology. doi:10.1182/blood-2009-03-208355.
clinicaltrials.govStudy
Filgrastim-Mobilized Stem Cells for Transplantation Using Unrelated Donors
1997. "Filgrastim-Mobilized Stem Cells for Transplantation Using Unrelated Donors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00785525.
All > Minnesota > Paid Studies Wisconsin
~10329 spots leftby Jan 2030
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top