NCT02438904

Brief Summary

Objectives: Primary Objective To provide compassionate access to the Miltenyi device for CD34+ cell infusions to patients who experience poor graft function after stem cell transplantation (SCT).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
12mo left

Started May 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
May 2015May 2027

First Submitted

Initial submission to the registry

May 6, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

May 6, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 8, 2015

Completed
12 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

December 1, 2025

Status Verified

November 1, 2025

Enrollment Period

12 years

First QC Date

May 6, 2015

Last Update Submit

November 24, 2025

Conditions

Blood And Marrow Transplantation

Keywords

Blood And Marrow TransplantationStem cell transplantationSCTPoor graft functionCD34+ cell infusion

Outcome Measures

Primary Outcomes (1)

  • Increased Graft Function after Stem Cell Transplantation (SCT)

    Blood drawn for signs of graft versus host disease (GVHD).

    4 weeks

Study Arms (1)

CD34 Positive Stem Cell Infusion

EXPERIMENTAL

Participants infused by vein with around 1 - 4 million/kg CD34+ selected cells. If the first infusion is not effective, an additional infusion may be given 4 - 6 weeks after the first infusion.

Biological: CD34 Positive Stem Cell InfusionDevice: Miltenyi device

Interventions

CD34 Positive Stem Cell InfusionBIOLOGICAL

Participants infused by vein with around 1 - 4 million/kg CD34+ selected cells.

CD34 Positive Stem Cell Infusion
Miltenyi deviceDEVICE

Miltenyi device is used for CD34+ cell infusions) to patients who experience poor graft function after stem cell transplantation (SCT).

Also known as: CliniMACS device
CD34 Positive Stem Cell Infusion

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \) Patients who have poor or no graft function post stem cell transplantation.

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

Study Officials

  • Elizabeth Shpall, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Shpall, MD

CONTACT

713-745-2161eshpall@mdanderson.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2015

First Posted

May 8, 2015

Study Start

May 6, 2015

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

December 1, 2025

Record last verified: 2025-11

Locations

US(1)