NCT02026934

Brief Summary

CliniMACs is an investigational device used to select and enrich stem cells. The device will select the stem cells with CD34+ protein. The participant will be infused with the CD34+ selected cells in the hopes that it will help the participant engraft. Engraftment is when transplanted stem cells resume production of healthy blood cells.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 3, 2014

Completed
Last Updated

November 21, 2016

Status Verified

November 1, 2016

First QC Date

January 2, 2014

Last Update Submit

November 18, 2016

Conditions

Graft-Versus-Host Disease(GVHD)Anemia Due to Disturbance of Proliferation and/or Differentiation of Hematopoietic Stem CellsGraft FailureDelayed Graft Function

Keywords

Graft-Versus-Host Disease(GVHD)Hematopoietic Stem Cell Transplantation.Graft failureGraft exhaustion

Interventions

CliniMACS CD34 Reagent SystemDEVICE

Following screening and enrollment, peripheral blood or bone marrow collection will be performed on the donor followed by subsequent CD34+ cell selection using the Miltenyi CliniMACS device. There is no limit to the number of CD34+ progenitors that can be administered. The CD34+ selected cells will be infused within 12 hours of the initiation of processing.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged \>18 years
  • Diagnosis is graft exhaustion.
  • Ability to understand and willingness to sign a written informed consent document
  • Matched related or unrelated donor must consent to provide an allograft.

You may not qualify if:

  • Symptomatic or uncontrolled cardiac failure or coronary artery disease.
  • Karnofsky performance status \< 60%.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Graft vs Host DiseaseDelayed Graft Function

Condition Hierarchy (Ancestors)

Immune System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sarah Nikiforow, MD, PhD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
expanded access
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sponsor/Co-Investigator

Study Record Dates

First Submitted

January 2, 2014

First Posted

January 3, 2014

Study Start

March 1, 2013

Last Updated

November 21, 2016

Record last verified: 2016-11

Locations

US(1)