90 Participants Needed

CliniMACS® T-Cell Depletion for Stem Cell Transplant Patients

CC
Overseen ByChristopher C. Dvorak, MD
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Christopher Dvorak
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

Patients in need of an allogeneic hematopoietic cell transplant (HCT) are at risk of developing graft-versus-host-disease (GVHD). In certain clinical situations, the optimal approach to minimize the risk of GVHD is to perform ex vivo alpha-beta T-cell depletion of the donor cells. However, the CliniMACS® Device is FDA-approved only for a narrow indication. All other uses of ex vivo processed cells must be done under a feasibility study protocol.

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 effectiveness of the CliniMACS® T-Cell Depletion treatment for stem cell transplant patients?

Research shows that the CliniMACS system effectively purifies and recovers CD34+ cells (important stem cells) while efficiently removing T cells, which can help reduce complications in stem cell transplants. This method has been used successfully in both children and adults with severe blood disorders and autoimmune diseases, showing higher purity and recovery rates compared to other methods.12345

Is CliniMACS® T-Cell Depletion safe for humans?

The CliniMACS® system, used for T-cell depletion in stem cell transplants, has shown consistent safety in studies, with no endotoxins (harmful substances) detected and negative results for bacterial contamination. It has been used successfully in both children and adults for various conditions, indicating a generally safe profile.12356

How is the CliniMACS® treatment different from other treatments for stem cell transplant patients?

The CliniMACS® treatment is unique because it uses a magnetic separation technique to efficiently deplete T cells from stem cell grafts, resulting in higher purity and recovery of CD34+ cells compared to other methods. This approach helps reduce the risk of complications like graft-versus-host disease in stem cell transplants.12357

Research Team

CC

Christopher C Dvorak, MD

Principal Investigator

Professor of Clinical Pediatrics

Eligibility Criteria

This trial is for males and females aged 0-30 needing a stem cell transplant due to certain diseases, with donors available who can give bone marrow or blood stem cells. It's not for those with identical related donors (unless they have Fanconi Anemia), life expectancy under one month, mouse protein or iron dextran allergies, pregnant/breastfeeding individuals, or if birth control isn't used.

Inclusion Criteria

Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study
I have a healthy donor ready to give bone marrow or stem cells.
My condition requires a stem cell transplant.
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Exclusion Criteria

Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
I have a healthy, willing, and HLA-matched relative to donate (unless I have Fanconi Anemia).
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive alpha-beta T-cell depleted stem cell transplants using the CliniMACS system

Up to 30 days
Multiple visits for infusion and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including engraftment and GVHD evaluations

12 months
Regular visits for monitoring and assessments

Long-term follow-up

Participants are monitored for long-term outcomes such as transplant-related mortality and chronic GVHD

12 months

Treatment Details

Interventions

  • CliniMACS®
Trial Overview The study tests the CliniMACS® Device's ability to remove specific T-cells from donor cells before transplant to prevent graft-versus-host disease. This process is being evaluated as it's currently only FDA-approved for limited use and needs further investigation in other settings.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Patients receiving allogeneic hematopoietic cell transplantExperimental Treatment1 Intervention
The test product is a stem cell product which has been alpha-beta T- cell depleted using the CliniMACS system. Alpha-beta T-cell depleted cells are given intravenously over a period of time as dictated by the final volume of the infused product (5 ml/kg/hour). The target dose of CD34+ cells is ≥20x10\^6/kg, but a minimum of ≥2.5x10\^6/kg is required. The target dose of T-cell receptor (TCR) alpha-beta CD3+ cells is ≤1x10\^5/kg.

CliniMACS® is already approved in United States, European Union for the following indications:

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Approved in United States as CliniMACS CD34 Reagent System for:
  • Prevention of graft-versus-host disease (GVHD) in patients with acute myeloid leukemia (AML) in first complete remission undergoing allogeneic hematopoietic cell transplant from a matched related donor
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Approved in European Union as CliniMACS System for:
  • Available as CE-marked medical devices for various cell separation and processing applications, but specific indications are not detailed beyond general use for hematopoietic cell processing

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Who Is Running the Clinical Trial?

Christopher Dvorak

Lead Sponsor

Trials
2
Recruited
90+

Findings from Research

The study evaluated two methods for T cell depletion in peripheral blood stem cell grafts, finding that the CliniMACS system provided higher purity (94.87%) and recovery (58%) of CD34+ cells compared to the CellPro system, which had a purity of 85.6% and recovery of 24.8%.
Both methods are deemed suitable for preparing stem cell grafts for mismatched transplants in patients with severe hematological disorders and for autologous transplants in autoimmune diseases, but the CliniMACS system is preferred due to its superior efficiency in T cell removal.
Comparison of two different methods for CD34+ selection and T cell depletion in peripheral blood stem cell grafts--our experiences with CellPro, E rosetting and CliniMACS technique.Poloucková, A., Vodvárková, A., Kobylka, P., et al.[2006]
The use of the CliniMACS Plus system for CD34+ cell enrichment in allogeneic stem cell transplantation achieved an average product purity of 95.66%, indicating a high-quality process that enhances the potential for using partially matched grafts without increasing the risk of graft-versus-host disease.
All end products tested negative for bacterial contamination and endotoxins, demonstrating the safety and reliability of the manufacturing process, which was validated across six different cycles.
A CD34+ Cell Enrichment Protocol of Hematopoietic Stem Cells in a Well-Established Quality Management System.Kilic, P., Bay, M., Yildirim, Y., et al.[2020]
The CliniMACS Prodigy system successfully automates the selection of CD34+ hematopoietic stem cells (HSCs) from apheresis products, achieving a high recovery rate of 74% with excellent cell viability of 99.9%.
The automated process maintains comparable quality to previous manual methods, ensuring similar CD34+ cell recovery and T-cell content, making it suitable for routine clinical use in generating T-cell-depleted stem cell grafts.
Automated CD34+ cell isolation of peripheral blood stem cell apheresis product.Spohn, G., Wiercinska, E., Karpova, D., et al.[2018]

References

Comparison of two different methods for CD34+ selection and T cell depletion in peripheral blood stem cell grafts--our experiences with CellPro, E rosetting and CliniMACS technique. [2006]
A CD34+ Cell Enrichment Protocol of Hematopoietic Stem Cells in a Well-Established Quality Management System. [2020]
Automated CD34+ cell isolation of peripheral blood stem cell apheresis product. [2018]
Haploidentical bone marrow transplantation in Mexico. [2012]
Depletion of αβ+ T and B Cells Using the CliniMACS Prodigy: Results of 10 Graft-Processing Procedures from Haploidentical Donors. [2022]
Improved immunomagnetic enrichment of CD34(+) cells from umbilical cord blood using the CliniMACS cell separation system. [2021]
[An effective method for T-cell and B-cell simultaneous depletion in vitro from mobilized peripheral blood stem/progenitor cell graft for haploidentical transplantation]. [2017]