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Definition of the Status of the Human Lung Stem Cell Niches ex Vivo in Tissue Biopsies Performed in Patients With Emphysema and Interstitial Fibrosis

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ClinicalTrials.gov Identifier: NCT02705144
Recruitment Status : Unknown
Verified March 2016 by Dr. Tiberiu Shulimzon MD, Sheba Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : March 10, 2016
Last Update Posted : March 10, 2016
Sponsor:
Collaborator:
Weizmann Institute of Science
Information provided by (Responsible Party):
Dr. Tiberiu Shulimzon MD, Sheba Medical Center

Brief Summary:

To characterize stem cell compartments in their niches in different clinical situations (non-diseased compared to emphysematous and fibrotic pulmonary tissue) and to assess their proliferative and developmental properties in vitro.

To further implement lung organoid culture system in the drug screening and development of patient personalized medicine.


Condition or disease Intervention/treatment
Lung Diseases, Interstitial Other: analysis of the number of stem cell niches

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Definition of the Status of the Human Lung Stem Cell Niches ex Vivo in Tissue Biopsies Performed in Patients With Emphysema and Interstitial Fibrosis Compared to Non-diseased Areas
Study Start Date : March 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Emphysema

Group/Cohort Intervention/treatment
biopsies from lung tissue affected by emphysema
analysis of the number of stem cell niches
Other: analysis of the number of stem cell niches
to assess stem cell compartments in their niches and their proliferative and developmental properties in vitro

biopsies from lung tissue affected by interstitial fibrosis
analysis of the number of stem cell niches
Other: analysis of the number of stem cell niches
to assess stem cell compartments in their niches and their proliferative and developmental properties in vitro

biopsies from normal appearance lung tissue
analysis of the number of stem cell niches
Other: analysis of the number of stem cell niches
to assess stem cell compartments in their niches and their proliferative and developmental properties in vitro




Primary Outcome Measures :
  1. The number of stem cell compartments in their niches in different clinical situations (non-diseased compared to emphysematous and fibrotic pulmonary tissue) . [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. The number of organoids in their cellular positions [ Time Frame: 2 years ]

Biospecimen Retention:   Samples With DNA
Lung tissue biopsies


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with lung emphysema and interstitial lung disease as the background for lung cancer
Criteria

Inclusion Criteria:

  • lung emphysema, lung interstitial fibrosis, lung cancer patients

Exclusion Criteria:

  • lung infectious diseases (bronchiectasis, lung abscess, pneumonia)
  • pulmonary edema

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02705144


Locations
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Israel
Sheba Medical Center
Tel Hashomer, Israel
Sponsors and Collaborators
Sheba Medical Center
Weizmann Institute of Science

Publications:
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Responsible Party: Dr. Tiberiu Shulimzon MD, Director Interventional Pulmonology Unit, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02705144     History of Changes
Other Study ID Numbers: SMC -15 - 2787
First Posted: March 10, 2016    Key Record Dates
Last Update Posted: March 10, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Interstitial
Emphysema
Pathologic Processes
Respiratory Tract Diseases