Haploidentical Transplant for Blood Disorders
Trial Summary
Do I need to stop my current medications for this trial?
The trial protocol does not specify whether you need to stop taking your current medications.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the idea that Haploidentical Transplant for Blood Disorders is an effective treatment?
The available research shows that Haploidentical Transplant for Blood Disorders, when combined with umbilical cord blood, can lead to successful outcomes. In one study, 83% of patients experienced successful engraftment, which means the transplanted cells started to grow and produce healthy blood cells. Additionally, the study reported a 54% overall survival rate at one year, indicating that more than half of the patients were still alive after a year. This suggests that the treatment can be effective for patients who do not have a fully matched donor. Compared to other methods, such as using two mismatched cord blood units, this approach provides a viable alternative with rapid recovery of blood cells and a lower risk of complications like graft-versus-host disease, where the new immune cells attack the patient's body.12345
What data supports the effectiveness of the treatment Haploidentical CD34+ Selected Cells Combined With Single Unit Umbilical Cord Blood Transplant?
Research shows that using a combination of haploidentical CD34+ selected cells and umbilical cord blood can lead to rapid recovery of blood cells and a good chance of successful engraftment, with 83% of patients achieving this by day 60. This approach also has a relatively low incidence of severe graft-versus-host disease, a common complication in transplants.12345
What safety data is available for haploidentical transplants for blood disorders?
The safety data for haploidentical transplants, including those using CD34+ selected cells combined with umbilical cord blood, indicates that this approach can result in rapid engraftment with no increased rate of graft failure or graft-versus-host disease (GVHD). In a study of 26 patients, the incidence of grade 2-4 acute GVHD was 27% at day +100, and chronic GVHD was 4% at 1 year. Overall survival at 1 year was 54%. Recent advances have reduced historical issues of graft rejection and severe GVHD, making haploidentical stem cell transplantation a viable option for patients without a fully matched donor. However, post-transplant infectious complications and relapse remain challenges.16789
Is haploidentical transplant generally safe for humans?
Haploidentical transplants, which use a partially matched family donor, have shown promising safety results. Studies indicate that recent advances have reduced issues like graft rejection and severe graft-versus-host disease (a condition where the donor's immune cells attack the recipient's body), making it a viable option for those without fully matched donors.136710
Is the treatment Haploidentical CD34+ Selected Cells Combined With Single Unit Umbilical Cord Blood Transplant a promising treatment for blood disorders?
Yes, this treatment is promising because it provides an alternative for patients who don't have a fully matched donor. It allows for nearly immediate donor availability and has shown improved outcomes over the past decade. This approach helps meet the need for stem cell transplants, especially for those with diverse backgrounds or urgent needs.1011121314
How is the treatment Haploidentical CD34+ Selected Cells Combined With Single Unit Umbilical Cord Blood Transplant different from other treatments for blood disorders?
This treatment is unique because it combines haploidentical stem cells, which are partially matched from a family member, with umbilical cord blood cells, allowing for a broader range of donor options and potentially faster availability. It addresses the challenge of finding fully matched donors and aims to improve outcomes by using both sources to enhance engraftment and immune recovery.1011121314
What is the purpose of this trial?
This is a study to evaluate the safety and efficacy of Miltenyi CliniMACS® CD34 Reagent System to promote engraftment of haploidentical CD34+ selected cells combined with single unit umbilical cord blood transplant for treatment of high-risk hematologic disorders.
Research Team
Jonathan Gutman, MD
Principal Investigator
University of Colorado, Denver
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Conditioning Regimen
Recipients receive a standard conditioning regimen before transplantation
Transplantation
Participants receive an allograft containing donor CD34+ cells and a single UCB unit
Engraftment Monitoring
Participants are monitored for successful engraftment and treatment-related serious adverse events
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Haploidentical CD34+ Selected Cells Combined With Single Unit Umbilical Cord Blood Transplant
- Miltenyi CliniMACS® CD34 Reagent System
Haploidentical CD34+ Selected Cells Combined With Single Unit Umbilical Cord Blood Transplant is already approved in United States for the following indications:
- Processing hematopoietic progenitor cells collected by apheresis (HPC, Apheresis) from an allogeneic, HLA-identical, sibling donor to obtain a CD34+ cell-enriched population for hematopoietic reconstitution following a myeloablative preparative regimen without the need for additional graft versus host disease (GVHD) prophylaxis in patients with acute myeloid leukemia (AML) in first morphologic complete remission.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor