CliniMACS CD34 Reagent system for Allogeneic

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Allogeneic+1 More
CliniMACS CD34 Reagent system - Device
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This trial is for people with a disease that requires a stem cell transplant, but don't have a perfect match. A close relative has been identified whose stem cells are not a perfect match, but can be used. The donor's blood cells are treated to minimize cells that are most likely to attack the patient's tissues.

Eligible Conditions
  • Allogeneic
  • Hematopoietic stem cells

Treatment Effectiveness

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 1 year

1 year
Assessment of Long Term Survival
100 days
For Both Cohorts: The total incidence of overall acute GvHD (greater than or equal to grade 3)
50 days
For Cohort 1: the rate of primary engraftment 50 days post SCT

Trial Safety

Trial Design

2 Treatment Groups

Cohort 2: CD34+ cells as a top off
1 of 2
Cohort 1: CD34+ Cells for transplant
1 of 2
Experimental Treatment

144 Total Participants · 2 Treatment Groups

Primary Treatment: CliniMACS CD34 Reagent system · No Placebo Group · N/A

Cohort 2: CD34+ cells as a top off
Device
Experimental Group · 1 Intervention: CliniMACS CD34 Reagent system · Intervention Types: Device
Cohort 1: CD34+ Cells for transplant
Device
Experimental Group · 1 Intervention: CliniMACS CD34 Reagent system · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year

Who is running the clinical trial?

Center for Cell and Gene Therapy, Baylor College of MedicineOTHER
108 Previous Clinical Trials
2,659 Total Patients Enrolled
The Methodist Hospital Research InstituteOTHER
236 Previous Clinical Trials
35,308 Total Patients Enrolled
Baylor College of MedicineLead Sponsor
914 Previous Clinical Trials
5,981,895 Total Patients Enrolled
Robert Krance, MD5.01 ReviewsPrincipal Investigator - Baylor College of Medicine
Baylor College of Medicine
5 Previous Clinical Trials
75 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a serious or life-threatening disease or condition that is incurable.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 4th, 2021

Last Reviewed: October 18th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.