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Hematopoietic Stem Cell Transplantation

Lung and Bone Marrow Transplant for Pulmonary Fibrosis

Phase 1 & 2

Recruiting

Research Sponsored by Paul Szabolcs

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have evidence of end stage lung disease such as Pulmonary Fibrosis or COPD/Emphysema

Male or female, 18 through 60 years old, inclusive, at the time of informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years post stem cell transplant

Awards & highlights

Study Summary

This trial is testing whether having a lung transplant before a bone marrow transplant helps improve lung function before the marrow transplant.

Who is the study for?

This trial is for adults aged 18-60 with severe lung diseases like Pulmonary Fibrosis or COPD and bone marrow failure, who are eligible for a lung transplant. They must understand the study, not be pregnant, agree to birth control post-transplant, and have no allergies to stem cell product ingredients or recent live vaccines.Check my eligibility

What is being tested?

The study tests if performing a lung transplant before a bone marrow transplant can restore lung function enough to proceed with bone marrow transplantation using various drugs (Rituximab, Alemtuzumab) and stem cells to improve blood cell counts.See study design

What are the potential side effects?

Potential side effects include reactions to medications such as Rituximab and Alemtuzumab (infusion reactions), low blood counts from chemotherapy agents like Fludarabine and Thiotepa, increased risk of infections due to immune suppression, and organ toxicity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have advanced lung disease like Pulmonary Fibrosis or COPD.

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I am between 18 and 60 years old.

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I am eligible for a lung transplant according to UNOS standards.

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I understand the study and can give my consent.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years post stem cell transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years post stem cell transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years post stem cell transplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

BOS Score

Death

Engraftment failure

+5 more

Secondary outcome measures

Ability to withdrawal immunosuppression

Acute cellular rejection

Acute graft-versus-host-disease (GVHD)

+9 more

Other outcome measures

In vitro immune tolerance

Mixed chimerism

Pace of immune reconstitution

Trial Design

1Treatment groups

Experimental Treatment

Group I: Lung and Bone Marrow TransplantationExperimental Treatment7 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rituximab

1999

Completed Phase 4

~1880

Alemtuzumab

2004

Completed Phase 4

~1890

Fludarabine

2012

Completed Phase 3

~1100

Thiotepa

2008

Completed Phase 3

~2210

G-CSF

2014

Completed Phase 4

~1610

Hydroxyurea

2006

Completed Phase 4

~3620

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Paul SzabolcsLead Sponsor

7 Previous Clinical Trials

224 Total Patients Enrolled

Media Library

Bone Marrow Transplantation (Hematopoietic Stem Cell Transplantation) Clinical Trial Eligibility Overview. Trial Name: NCT03500731 — Phase 1 & 2

Idiopathic Pulmonary Fibrosis Research Study Groups: Lung and Bone Marrow Transplantation

Idiopathic Pulmonary Fibrosis Clinical Trial 2023: Bone Marrow Transplantation Highlights & Side Effects. Trial Name: NCT03500731 — Phase 1 & 2

Bone Marrow Transplantation (Hematopoietic Stem Cell Transplantation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03500731 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What effects are researchers expecting to observe in participants of this study?

"The primary outcome of this trial, observed for up to two years following stem cell transplantation, is the measurement of myeloid chimerism. Secondary objectives include independence (defined as those able to abstain from transfusions and growth factors for at least one month), abilityto wean off immunosuppression (the number who are able to start withdrawing immunosuppresion) and chronic graft-versus-host disease (GVHD; defined as the number developing such)."

Answered by AI

Are there any opportunities still available to join this clinical experiment?

"Affirmative. According to clinicaltrials.gov, this healthcare research initiative is currently recruiting volunteers and was first posted on April 19th 2018 with the last edit being made February 9th 2022. This experiment seeks 8 individuals from two distinct locations."

Answered by AI

What is the maximum participant capacity for this medical trial?

"Affirmative. According to the information hosted on clinicaltrials.gov, this research is actively recruiting patients after its initial post date of April 19th 2018 and last updated on February 9th 2022. A total of 8 candidates from 2 trial sites are necessary for completion."

Answered by AI

Does this experiment permit participants aged 25 or older?

"The parameters of this clinical trial are limited to those aged 18-60. Those younger than 18 or older than 65 may find suitable trials in the other 365 and 1122 respective studies available."

Answered by AI

What evidence exists in regards to the efficacy of CD3/CD19 negative hematopoietic stem cells?

"Currently, 894 clinical trials dedicated to CD3/CD19 negative hematopoietic stem cells are in progress with 150 of those studies being conducted at Phase 3. While Philadelphia, Pennsylvania hosts the highest concentration of such experiments, other locations spanning 21121 cities across the world also have their own ongoing research initiatives."

Answered by AI

How often is CD3/CD19 negative hematopoietic stem cells employed therapeutically?

"CD3/CD19 negative hematopoietic stem cells are a common form of treatment for polyangium, as well as various other forms of cancer such as leukemia, myelocytic acute malignancies, and thrombocythemia."

Answered by AI

Who is eligible to partake in this research endeavor?

"This clinical trial is sourcing 8 subjects aged 18 to 60 with usual interstitial pneumonia. Moreover, the participants must be qualified for organ transplant listing via UNOS and have experienced unexplained neutropenia (<1500/µL), thrombocytopenia (<100,000/µL) or anemia (< 12 g/dL) in the preceding year along with a GFR of 45 mL/min./1.73 m2or above. Finally, all applicants must comprehend their rights related to informed consent prior to joining this study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Lung and Bone Marrow Transplantation for Lung and Bone Marrow Failure

Paul Szabolcs 2018. "Lung and Bone Marrow Transplantation for Lung and Bone Marrow Failure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03500731.

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