← Back to Search

Cell Therapy

Haploidentical Transplant for Blood Disorders

N/A

Recruiting

Led By Jonathan Gutman

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Availability of at least one 4/6 HLA-matched (HLA-A, B, and DR loci) cord blood unit from the National Marrow Donor Program (NMDP). The cord blood unit must contain a minimum TNC (prior to thawing) of at least 2x107 cells per kilogram of recipient body weight

Availability of at least one HLA- haploidentical (i.e. => 5/10 and <= 8/10 HLA match) related donor (HLA-A, B, C, DR, and DQ loci) who is available to donate CD34+ cells.

Must not have

HLA identical (6/6) related donor available and readily accessible at time of transplantation evaluation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 42 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a certain cell-selection method can help patients with high-risk blood disorders by transplanting them with cells from a donor with a half-matched DNA.

Who is the study for?

This trial is for adults aged 18-80 with high-risk blood disorders who lack an exact HLA-matched donor but have a partially matched (5/10 to 8/10) relative and a suitable umbilical cord blood unit. It's not open to those with a fully matched (6/6) related donor or who don't meet standard transplant guidelines.

What is being tested?

The study tests the Miltenyi CliniMACS® CD34 Reagent System, aiming to improve how well patients accept stem cells from partly matched relatives combined with umbilical cord blood transplants in treating serious blood diseases.

What are the potential side effects?

Potential side effects may include immune system reactions, infection risk due to weakened immunity post-transplant, graft-versus-host disease where the new cells attack the body, and typical complications associated with stem cell transplants.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a cord blood match with at least 4/6 HLA compatibility and enough cells for my body weight.

Select...

I have a family donor who is a partial match for a stem cell transplant.

Select...

I understand the treatment I will be receiving.

Select...

I do not have a family member who is a perfect match for a bone marrow transplant.

Select...

I am between 18 and 80 years old.

Select...

I have a severe blood disorder that requires a stem cell transplant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a family donor who is a perfect match for my transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 42 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~42 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 42 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The number of patients with successful engraftment

The number of patients with treatment-related serious adverse event rate (TRSAE)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Miltenyi CliniMACS® CD34 Reagent SystemExperimental Treatment1 Intervention

The haploidentical donor will be mobilized by G-CSF and undergo one apheresis to collect CD34+ selected stem cell product after Miltenyi CliniMACS® CD34+ selection. The products will be cryopreserved until the time of transplantation. Recipients will receive a standard conditioning regimen. After the conditioning regimen, the subjects will receive an allograft on day 0 containing donor CD34+ cells that have been positively selected and T-cell depleted following G-CSF mobilization combined with a single UCB unit. UCB unit will not be manipulated, and will be prepared and infused separately following standard of care procedure.

0 / 7Eligibility criteria met