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

Sponsor

Mayo Clinic (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01860898

Collaborator

(none)

Enrollment

Location

Arm

168

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

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.

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	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

31 participants

Allocation:

N/A

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 :

Sep 1, 2009

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.

Arm

Intervention/Treatment

Other: 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.

Outcome Measures

Primary Outcome Measures

Feasibility [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.