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A Phase I Study of iPS Cell Generation From Patients With COPD

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ClinicalTrials.gov Identifier: NCT01860898
Recruitment Status : Active, not recruiting
First Posted : May 23, 2013
Last Update Posted : March 21, 2018
Sponsor:
Information provided by (Responsible Party):
Dennis Wigle, Mayo Clinic

Brief Summary:
As part of the long-term goal of successfully implementing tissue regeneration strategies in an individualized manner for patients with thoracic diseases including, but not limited to: cystic fibrosis, pulmonary fibrosis and pulmonary hypertension, the investigators will assess the feasibility of collecting skin biopsies from patients undergoing surgery for thoracic disease, culturing skin fibroblasts from the biopsy, and reprogramming these skin fibroblasts into induced pluripotent cells.

Condition or disease Intervention/treatment Phase
Thoracic Diseases Respiratory Tract Diseases Cancer of Lung Cancer of the Lung Lung Cancer Lung Diseases, Obstructive COPD Pulmonary Emphysema Neoplasms, Lung Neoplasms, Pulmonary Pulmonary Cancer Pulmonary Neoplasms Carcinoma, Non-Small-Cell Lung Carcinoma, Small Cell Other: Skin Biopsy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase I Study of iPS Cell Generation From Patients With COPD
Study Start Date : September 2009
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy
U.S. FDA Resources

Arm Intervention/treatment
Skin Biopsy Other: Skin Biopsy
Biopsy samples will be taken as a 2mm x 2cm excision of a wedge of skin at the edge of the incision during your surgery at the Mayo Clinic Rochester. Such excisions are frequently done as part of routine skin closure for optimal skin cosmesis following the surgical procedure.



Primary Outcome Measures :
  1. Feasibility [ Time Frame: 1 year ]
    As part of the long-term goal of successfully implementing tissue regeneration strategies in an individualized manner for patients with thoracic diseases including, but not limited to: cystic fibrosis, pulmonary fibrosis and pulmonary hypertension, we will assess the feasibility of collecting skin biopsies from patients undergoing surgery for thoracic disease, culturing skin fibroblasts from the biopsy, and reprogramming these skin fibroblasts into induced pluripotent cells. Markers of induced pluripotent phenotype will be utilized to assess successful reprogramming.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Undergoing Thoracic Surgery at the Mayo Clinic Rochester
  • Presence of a Thoracic Disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01860898


Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Dennis A Wigle, MD, PhD Mayo Clinic

Responsible Party: Dennis Wigle, M.D., P.h.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT01860898     History of Changes
Other Study ID Numbers: 09-005334
First Posted: May 23, 2013    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018

Keywords provided by Dennis Wigle, Mayo Clinic:
lung
cancer
thoracic
chest
pulmonary

Additional relevant MeSH terms:
Carcinoma, Small Cell
Carcinoma
Neoplasms
Lung Diseases
Emphysema
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Diseases
Lung Diseases, Obstructive
Pulmonary Emphysema
Lung Neoplasms
Thoracic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pathologic Processes
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Pulmonary Disease, Chronic Obstructive