Properties of Mesenchymal Stem Cells in Lung Transplant

NCT01668576 | Terminated

• 1 other identifier: IRB00053075
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The major limitation to long term survival in lung transplant recipients is the development of graft failure over time, termed bronchiolitis obliterans. The conventional therapies used to prevent rejection are not effective in preventing bronchiolitis obliterans. Therefore, new therapies are needed to address this problem. A growing body of research has focused on a unique population of bone marrow cells termed Mesenchymal Stem Cells (MSCs) to improve a range of medical conditions including heart failure, autoimmune disease, and inflammatory bowel disease. MSCs can prevent animal models of bronchiolitis obliterans. Because of this information, it is plausible that MSCs could help patients as a potential treatment in lung transplantation. This proposal will test the immunologic properties of MSCs generated from such individuals to answer the question of whether generation of whether it would be feasible to use such cells in the future to prevent entities such as bronchiolitis obliterans. The Investigator will approach patients who are being considered for a lung transplant because of end stage lung disease. Enrolled patients will undergo a bone marrow aspiration where a small amount of fluid is removed from their pelvic bone. Cells obtained in this procedure will be expanded in the Emory/Georgia Tech Cell Lab. MSCs will be expanded in this lab using cell culture conditions which are standardly used for MSCs.

Conditions

Lung Transplantation

Keywords

mesenchymal stem cells; Lung transplantation

Outcome Measures

Primary Outcomes (3)

• Intrinsic variability of MSCs measured by time to third passage of confluent MSC

  Assess for intrinsic variability of MSCs derived from individuals with end-stage lung disease across a range of ages, disease types, and comorbid conditions

  Post Co-Culture (24 hours)

• 2-3 IDO production measured as ug/mL of passage 3 MSCs

  Demonstrate autologous MSCs have in-vitro immunoregulatory properties against allo-specific T cell responses and compare the MSC effects to conditioned media from MSCs

  Post Co-Culture (24 hours)

• Percent specific inhibition of CD4 and CD8 T cell proliferation toward donor target cells in one way mixed-lymphocyte reactions

  Test the immunoregulatory properties of MSCs in the setting of conventional levels of immune suppression

  Post Co-Culture (24 hours)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Lung transplant candidates

You may qualify if:

• Patients aged 18-70 without regard to race or gender
• End stage lung disease from IPF, cystic fibrosis, emphysema, sarcoidosis or pulmonary hypertension
• Expected time from enrollment to transplant greater than 4 weeks
• Patient willing to undergo a bone marrow aspiration prior to transplantation

You may not qualify if:

• Patients under age 18
• Patients on significant immunosuppressive agents prior to transplant (specifically calcineurin inhibitors, cell cycle inhibitors or prednisone \>0.5 mg/kg lean body weight)

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

mesenchymal stem cells derived from subject bone marrow aspiration

Study Officials

• David Neujahr, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 15, 2012
• First Posted: August 20, 2012
• Study Start: August 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: January 14, 2016

Record last verified: 2016-01

Locations

US (1)