Lung and Bone Marrow Transplantation for Lung and Bone Marrow Failure

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Paul Szabolcs
Study ID
NCT03500731
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Emphysema or COPD
  • Idiopathic Pulmonary Fibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • CD3/CD19 negative hematopoietic stem cells — BIOLOGICAL
    Negative selection for CD3/CD19 will be performed on CliniMACS® depletion device and given at time no less than 8 weeks post lung transplantation
  • Rituximab — DRUG
    Transplantation Conditioning
  • Alemtuzumab — DRUG
    Transplantation Conditioning
  • Fludarabine — DRUG
    Transplantation Conditioning
  • Thiotepa — DRUG
    Transplantation Conditioning
  • G-CSF — DRUG
    Transplantation conditioning
  • Hydroxyurea — DRUG
    Transplantation Conditioning

Study Details

The purpose of this study is to determine whether a lung transplantation prior to bone marrow transplantation (BMT) would allow for restoration of pulmonary function prior to BMT, allowing to proceed to BMT, to restore hematologic function.

Key Dates

Start date
Apr 19, 2018
Status verified
Jan 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
8 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Lung and Bone Marrow Transplantation
    All patients will undergo a cadaveric, partially HLA-matched lung transplantation followed by a CD3+/CD19+ depleted BMT from the same donor. In this study, the investigators will use a ≥1/6 HLA-matched T cell depleted bone marrow transplantation from a cadaveric organ donor with an identical ABO blood type as the recipient. Prior to transplantation, the marrow will be negatively selected for CD3/CD19 using a CliniMACS® depletion device. Subjects will undergo lung transplantation utilizing standard induction regimens selected by the CO-PIs based on the subject's underlying comorbidities and allosensitization. Rituximab may be initiated prior to the lung transplantation with tacrolimus as the ongoing maintenance immunosuppression. Subjects will undergo BMT utilizing CD3+/CD19+-depleted bone marrow with bone marrow conditioning beginning no less than 8 weeks after lung transplantation. Bone marrow will be recovered alongside solid organs and will be processed and cryopreserved.

Primary Outcome Measure

Death [ Time Frame: Up to 2 years post stem cell transplant ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Children's Hospital of Pittsburgh of UPMCPittsburghPennsylvania15224
Shawna H McIntyre, RN
[email protected]
412-692-5552
Paul Szabolcs, MD (PRINCIPAL_INVESTIGATOR)
UPMC PresbyterianPittsburghPennsylvania15214
John McDyer, MD
[email protected]
412-648-6161

Find similar trials in Pittsburgh, PA

By research site
Children's Hospital of Pittsburgh of UPMC· Pittsburgh, PAUPMC Presbyterian· Pittsburgh, PA

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