Autologous Stem Cell Treatment for Chronic Lung Disease Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

207 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-01

Study Completion Date

2017-06-09

Brief Summary

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The purpose of the Lung Institute is to collect and isolate a patient's own cells and platelet rich plasma (PRP) and deliver the product back to the patient the same day. Lung Institute's treatment is limited to self-funded patients with chronic lung disease- chronic obstructive pulmonary disease (COPD) and restrictive lung diseases such as pulmonary fibrosis (PF) and interstitial lung disease (ILD). The patient's cells and platelet rich plasma are harvested through venous or bone marrow collection techniques.

The hypothesized outcomes of therapy are safety and minimization of adverse events, a perceived improvement in the patient's lung condition (to be determined by their perceived quality of life), an improvement in the FEV1 among COPD patients, the ability to reduce supplemental oxygen use, the ability to function well without the use of rescue inhalers, reduction of secondary pulmonary infections, reduction in emergency room visits and exacerbations related to their disease.

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Detailed Description

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Through the collection of outcomes data, Lung Institute aims to explore and describe the safety and efficacy of autologous stem cell treatment for chronic lung disease with dissemination to the public and to the medical community for the advancement of regenerative medicine. The study aims to confirm the safety of autologous cell therapy, explore the effect of autologous cell therapy treatment on pulmonary function over time, and to describe the anecdotal quality of life changes of patients following treatment using quantitative and qualitative measures.

Conditions

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COPD Interstitial Lung Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cell therapy treated

All patients/participants enrolled will undergo cell therapy

Cell therapy

Intervention Type PROCEDURE

Each participant will receive cell therapy with stem cells harvested either from peripheral blood or from bone marrow plus peripheral blood; after harvest, cells are processed and returned to the patient via peripheral circulation on the same day.

Interventions

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Cell therapy

Each participant will receive cell therapy with stem cells harvested either from peripheral blood or from bone marrow plus peripheral blood; after harvest, cells are processed and returned to the patient via peripheral circulation on the same day.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients are included in treatment by self-referral and after consultation with a designated patient coordinator who determines initial eligibility, and then by the clinic nurse practitioner or physician of Lung Institute who determines final eligibility for inclusion. All eligible treated patients are eligible for the study.

Exclusion Criteria

* Patients who are unable to provide informed consent, pregnant patients, prisoners, non-English speakers, patients with a history of cancer within the past 5 years, patients with active tuberculosis or pneumonia. In addition, patients on prescribed blood thinners, with a history of breast or prostate cancer of any time frame or with a history of osteoporosis are excluded from the bone marrow harvest option.

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No