Peripheral Blood Stem Cell Transplantation Using the CliniMACS Device

Medical College of Wisconsin60 enrolled

Overview

T cell depletion utilizing the CliniMACS device will allow more precise, specific and controlled graft engineering of peripheral blood stem cells from unrelated and partially matched related donors without an increase in relapse or graft rejection and grade III or IV acute graft versus host disease (GVHD).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Malignant Diseases (ie, Leukemia, MDS, Lymphoma)Non-malignant Diseases (ie, Bone Marrow Failure Syndromes)

Interventions

CliniMACS (CD+3, CD+19 depletion)DEVICE

Patient's in Stratum 1 will receive grafts that have undergone CD3+, CD19+ depletion

CliniMACS (CD 34+ positive selection)DEVICE

Patient's in Stratum 2 will receive peripheral blood progenitor cells that have undergone CD34+ selection

HSCTOTHER

Peripheral Blood Stem Cell Transplant

Eligibility

Sex: ALLMax age: 22 Years

Medical Language ↔ Plain English

Inclusion Criteria: * All races are eligible * Malignant diseases: Leukemias and Lymphomas * Non-malignant diseases: Severe Aplastic Anemia, immunodeficiencies Exclusion Criteria: * Lansky or Karnofsky \> 70 * Echo \> 27% shortening fraction * renal function:serum creatinine \< 1.5 x for normal age * no active untreated infection * DLCO \> 50% of predicted value * Hepatic: AST and ALT \< 3x upper limit of normal; bilirubin \< 2.0.

Locations (1)

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, United States

Outcomes

Primary Outcomes

To measure the incidence and quality of engraftment

Time frame: Weekly for first 100 days, 6 months and 1 year

Secondary Outcomes

Evaluate the incidence of acute Graft versus Health Disease and treatment related mortality.

Time frame: weekly for the first 100 days and then 6 and 12 months post transplant date

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.