Back to resultsA Phase I Study of iPS Cell Generation From Patients With COPD
Primary Purpose
Thoracic Diseases, Respiratory Tract Diseases, Cancer of Lung
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Skin Biopsy
Sponsored by
About this trial
This is an interventional basic science trial for Thoracic Diseases focused on measuring lung, cancer, thoracic, chest, pulmonary
Eligibility Criteria
Inclusion Criteria:
- Undergoing Thoracic Surgery at the Mayo Clinic Rochester
- Presence of a Thoracic Disease
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Skin Biopsy
Arm Description
Outcomes
Primary Outcome Measures
Feasibility
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01860898
Brief Title
A Phase I Study of iPS Cell Generation From Patients With COPD
Official Title
A Phase I Study of iPS Cell Generation From Patients With COPD
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
October 28, 2014 (Actual)
Study Completion Date
October 28, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
lung, cancer, thoracic, chest, pulmonary
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Skin Biopsy
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Skin Biopsy
Intervention Description
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 Measure Information:
Title
Feasibility
Description
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.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Undergoing Thoracic Surgery at the Mayo Clinic Rochester
Presence of a Thoracic Disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis A Wigle, MD, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
A Phase I Study of iPS Cell Generation From Patients With COPD
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