An Observational Outcomes Study for Autologous Cell Therapy Among Patients With COPD and Interstitial Lung Disease
| Status: | Recruiting |
|---|---|
| Conditions: | Lung Cancer, Chronic Obstructive Pulmonary Disease, Pulmonary, Pulmonary |
| Therapuetic Areas: | Oncology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 16 - Any |
| Updated: | 3/9/2019 |
| Start Date: | January 3, 2017 |
| End Date: | April 5, 2020 |
| Contact: | Melissa Rubio, PhD |
| Email: | mrubio@lunginstitute.com |
| Phone: | 855-543-6299 |
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 same-day. Lung
Institute's treatment is limited to self- funded patients with chronic lung disease - chronic
obstructive pulmonary disease (COPD) and interstitial lung disease (ILD). The patient's cells
and platelet rich plasma are collected through venous or bone marrow harvesting techniques.
The hypothesized outcomes of Lung Institute therapy are safety and minimization of adverse
events, a perceived improvement in the patient's lung condition (to be determined by their
ability to be more physically active; walking greater distances with or without oxygen and
improved quality of life scales), an improvement in the FEV1 among COPD patients, the ability
to reduce their use of oxygen and possibly to stop it., the ability to function well without
the use of rescue inhalers, reduction or ceasing of secondary pulmonary infections, reduction
in emergency room visits and exacerbations related to their disease.
platelet rich plasma (PRP) and deliver the product back to the patient same-day. Lung
Institute's treatment is limited to self- funded patients with chronic lung disease - chronic
obstructive pulmonary disease (COPD) and interstitial lung disease (ILD). The patient's cells
and platelet rich plasma are collected through venous or bone marrow harvesting techniques.
The hypothesized outcomes of Lung Institute therapy are safety and minimization of adverse
events, a perceived improvement in the patient's lung condition (to be determined by their
ability to be more physically active; walking greater distances with or without oxygen and
improved quality of life scales), an improvement in the FEV1 among COPD patients, the ability
to reduce their use of oxygen and possibly to stop it., the ability to function well without
the use of rescue inhalers, reduction or ceasing of secondary pulmonary infections, reduction
in emergency room visits and exacerbations related to their disease.
Through the collection of outcome 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, and to describe the anecdotal
quality of life changes of patients following treatment using both quantitative and
qualitative measures.
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, and to describe the anecdotal
quality of life changes of patients following treatment using both quantitative and
qualitative measures.
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
nurse practitioner or physician of the Lung Institute who determines final eligibility
for treatment. All eligible and thereby traded 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.
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