CliniMACS® CD34+ Reagent System for Expanded Access Use | NCT02026934

Studies
CliniMACS® CD34+ Reagent System for Expanded Access Use

NCT02026934

Sponsor

Joseph Antin

Status

No longer available

Last Update Posted

Nov 21, 2016Estimated

Enrollment

Not provided

Phase

Not provided

Conditions

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

Interventions

CliniMACS CD34 Reagent System

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

No longer available

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Mar 2013

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jan 2, 2014

First Submission Date that Met QC Criteria

Jan 2, 2014

First Posted Date

Jan 3, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 18, 2016

Last Update Posted Date

Nov 21, 2016Estimated

Name	Class
Miltenyi Biomedicine GmbH	INDUSTRY

Description Module

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.

Detailed Description

After the screening procedures confirm that the participant is eligible to participate in the research study: If the participant takes part in this research study, the participant (and their donor) will have the following tests and procedures:
Donor Graft Collection: The participant's cell donor will undergo stem cell collection. The cells collected will be sent to the laboratory for processing.
Donor Graft Processing: In the laboratory the CliniMACS device will be used to separate the CD34+ stem cells from the other types of cells in the graft. After completing the necessary safety tests, the CD34+ selected donor graft will be ready for administration.
Donor Graft Infusion: The CD34+ selected donor graft will be infused through an intravenous (I.V.) catheter. The day of this infusion is called Day 0.
Follow-Up Visits: Approximately 3, 6 and 12 months after the donor graft infusion, the participant will return to clinic for follow-up visits. At each of the visits, the participant will have a physical exam and asked questions about your general health. The participant will also have routine blood tests performed (approximately 1 tablespoon of blood).
At times more cells are collected from a donation than are needed to do the transplantation. If your physician determines that it is preferable to administer a dose of cells that is less than the complete collection, the extra cells may be frozen and stored in our freezers for the participant's future use. If the cell counts do not improve, the participant will be given the remaining cells through an intravenous (I.V.) catheter.

Conditions Module

Conditions

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

Keywords

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

Design Module

Study Type

Expanded Access

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CliniMACS CD34 Reagent System	Device	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 Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sarah Nikiforow, MD, PhD	Dana-Farber Cancer Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dana Farber Cancer Institute		Boston	Massachusetts	02115	United States

Condition Browse Module

MeSH Terms

ID	Term
D006086	Graft vs Host Disease
D051799	Delayed Graft Function

Ancestor Terms

ID	Term
D007154	Immune System Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

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