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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dennis Wigle, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01860898
First received: May 21, 2013
Last updated: September 9, 2014
Last verified: September 2014
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Phase I Study of iPS Cell Generation From Patients With COPD

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Feasibility [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: September 2009
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    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. Such excisions are frequently done as part of routine skin closure for optimal skin cosmesis following the surgical procedure.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Undergoing Thoracic Surgery
  • Presence of a Thoracic Disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Dennis Wigle, M.D., P.h.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT01860898     History of Changes
Other Study ID Numbers: 09-005334
Study First Received: May 21, 2013
Last Updated: September 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
lung
cancer
thoracic
chest
pulmonary

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

ClinicalTrials.gov processed this record on November 27, 2014