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N/A N=207

Autologous Stem Cell Treatment for Chronic Lung Disease Study

COPD · Interstitial Lung Disease

Enrolled (actual)
207
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcome: Primary: Change in FEV1 From Baseline Among COPD Patients — 12.8 percentage of change in FEV1

Study Design & Population

Study type
Observational
Phase
N/A
Interventions
Cell therapy (Procedure)
Age
Pediatric, Adult, Older Adult · 16+ yrs
Sex
All
Sponsor
Lung Institute
Primary completion
Jun 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in FEV1 From Baseline Among COPD Patients
12.8
PRIMARY
Number of Participants Reporting an Improvement in 3 Month-Post Treatment QOL Scores, All Diagnoses
121
PRIMARY
Number of Participants Reporting an Improvement in 6 Month-Post Treatment QOL Scores, All Diagnoses
90

Summary

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.

Eligibility Criteria

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03044431). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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