search
Back to results

A 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
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Thoracic Diseases focused on measuring lung, cancer, thoracic, chest, pulmonary

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
May 21, 2013
Last Updated
September 27, 2022
Sponsor
Mayo Clinic
search

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

We'll reach out to this number within 24 hrs