N/A
N=207
Autologous Stem Cell Treatment for Chronic Lung Disease Study
COPD · Interstitial Lung Disease
Bottom Line
View on ClinicalTrials.gov: NCT03044431 ↗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
| Outcome | Result | p-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.
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.