Compassionate Access of the Miltenyi Device for CD34+ Cell Selection

M.D. Anderson Cancer Center

Status: Enrolling

Conditions: Blood And Marrow Transplantation

Treatments: Biological: CD34 Positive Stem Cell Infusion; Device: Miltenyi device

Study type: Interventional

Funder types: Other

Identifiers

NCT02438904

NCI-2015-00979 (Registry Identifier)

2015-0295

Details and patient eligibility

About

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).

Full description

The therapy that you will receive involves you being given an infusion of CD34 positive stem cells.

Below is a detailed explanation of the therapeutic procedures that will be performed.

CD34 positive stem cells infusion:

The CD34 positive stem cells are collected from a donor's blood. The blood cells go through CD34 (stem cell) selection process that collects the stem cells that are needed for the infusion. This process collects the early immune cells your body will need to regrow your immune system, and makes sure that other cells will not be infused. This process will decrease (but not eliminate completely) the other types of cells. If you agree to receive this treatment, the CD34 cells will then be infused into your body.

The CD34 positive cells will be given by vein in either an inpatient or outpatient treatment area. The infusion will last about 10-30 minutes.

Before the infusion, you will receive Tylenol (acetaminophen) by mouth and Benadryl (diphenhydramine hydrochloride) by mouth or vein about 30-60 minutes before the infusion. These drugs will be used to help lower the risk of side effects. If side effects occur during the infusion, the doses of the drugs may be adjusted (up or down) until the symptoms are gone. Also, if you have side effects during the infusion, you will be observed for 2 hours after it is given or until the symptoms have stopped completely (whichever is later). During this time, your blood pressure, heart rate, breathing rate, temperature, and the level of oxygen in your blood will be checked every 15-30 minutes.

About 4-6 weeks after the first infusion, you may receive an additional infusion, if your doctor thinks it is needed.

Clinic Visits:

One (1) time a week after the infusion, until your doctor thinks it is no longer clinically needed, you will have the following tests:

• Blood (about 1 teaspoon) will be drawn for routine tests.
• You will be checked for signs of graft versus host disease (GVHD). Symptoms of GVHD include skin rash, nausea, vomiting, diarrhea, and abnormal liver function.

This is an investigational study. The CD34 positive stem cell infusion to help boost cell counts is not FDA approved.

Up to 75 patients will be enrolled on this treatment.

Enrollment: 200 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

N/A

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

CD34 Positive Stem Cell Infusion

Experimental group

Description:

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.

Treatment:

Device: Miltenyi device

Biological: CD34 Positive Stem Cell Infusion