CD34+ Cell Enriched and T Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Mismatched Related Donors or Borderline Organ Function

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2023-03-31

Brief Summary

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The purpose of this protocol is to provide access to the CliniMACS® System to hematopoietic cell transplant (HSCT) patients who do not have a matched related donor. The CliniMACS system is currently approved for use in patients who have AML, and a genetically matched sibling donor. Through this protocol, the investigators will be able to offer potentially life-saving transplants to patients who have genetically mis-matched donor, who have no other options for treatment.

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Detailed Description

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Conditions

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Malignant Diseases Non-malignant Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ARM A Malignant TBI

Malignant diseases Conditioning including total body irradiation and chemotherapy

Group Type EXPERIMENTAL

CliniMACS CD34+ cell enrichment and T-cell depletion

Intervention Type DEVICE

ARM B Malignant Non-TBI

Malignant diseases chemotherapy based conditioning

Group Type EXPERIMENTAL

CliniMACS CD34+ cell enrichment and T-cell depletion

Intervention Type DEVICE

ARM C Non-malignant

Non-malignant diseases Chemotherapy based conditioning

Group Type EXPERIMENTAL

CliniMACS CD34+ cell enrichment and T-cell depletion

Intervention Type DEVICE

Interventions

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CliniMACS CD34+ cell enrichment and T-cell depletion

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Participant age is 0 (newborn) to 35 years-old.
* Participant has a disorder affecting the hematopoietic system that are inherited, acquired, or a result from the myeloablative treatment that can benefit from alternative stem cell transplantation according to standard practice guidelines for including patients for transplant.
* Participant's medical screening clears s/he for allogeneic transplantation as per current institutional SOP based on standards of foundation for accreditation of cellular therapy and stem cell transplantation (FACT);
* Participant must lack a healthy, HLA-identical related or unrelated donor unless s/he has a borderline organ function that will preclude the recipient from receiving a curative therapy due to the need of post-HSCT immunosuppressive therapy.
* Participant must have a matched or mismatched-related donor who is:
* Able to receive granulocyte colony-stimulating factor (G-CSF) and undergo apheresis either through placement of catheters in antecubital veins or a temporary central venous catheter OR agrees on a bone marrow harvest;
* Healthy as per donor selection screening (following current SOP based on standards of foundation for accreditation of cellular therapy and stem cell transplantation - FACT);
* Willing to participate and sign consent.
* Participant or Legal Authorized Representative is able to sign informed consent (and signed assent, if applicable) for transplant.

Exclusion Criteria

* Participant does not qualify for an allogeneic transplant due to medical screening, underlying disease, or lack of alternative donors.
* Any condition that compromises compliance with the procedures of this protocol, as judged by the principal investigator.

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No