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

NCT01860898 | Completed

• 1 other identifier: 09-005334
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Study Arms (1)

Skin Biopsy

OTHER

Other: Skin Biopsy

Interventions

Skin Biopsy OTHER

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.

Skin Biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Thoracic Diseases; Respiratory Tract Diseases; Lung Neoplasms; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Carcinoma, Non-Small-Cell Lung; Carcinoma, Small Cell; Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Dennis A Wigle, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., P.h.D.

Study Record Dates

• First Submitted: May 21, 2013
• First Posted: May 23, 2013
• Study Start: September 1, 2009
• Primary Completion: October 28, 2014
• Study Completion: October 28, 2014
• Last Updated: September 28, 2022

Record last verified: 2022-09

Locations

US (1)