Autologous Cellular Therapy With PRP-PC in Chronic Lung Diseases: An Observational Study LI-004

Completed

• Conditions: COPD ILD

• Registration Number: NCT05562843
• Lead Sponsor: H-CYTE

Brief Summary

For this study, cells will be harvested from the patient from the peripheral blood, isolated and concentrated using proprietary Emcyte™ equipment/centrifugation, and then returned to the patient same day via the peripheral circulation. As circulation occurs, the concentrated cells enter the right heart and are then disseminated into the lungs, becoming trapped in the lung's microcirculation. Here, the cells are believed to produce multiple bioactive factors such as cytokines and anti-inflammatory mediators. Several growth factors are released by activated platelets becoming honing cells for healing within the tissue. The exact long-term mechanism of action of PRP-PC in the lungs remains under investigation. Safety studies have proven that autologous treatment is incredibly safe, largely because of the minimal cell manipulation and the autologous nature of the cells. Prior observational studies in this are have shown strong safety profiles as well as strong efficacy in both COPD and ILD.

Detailed Description

Study Objective(s) Primary

* To determine if pulmonary function improves following ceullar therapy Secondary

* To determine if participants' perceived quality of life related to breathing improves following cellular therapy To evaluate the safety of autologous PRP-PC administration for chronic lung disease

Study Timeline

• Study Start: 2021-06-10
• Primary Completion: 2022-08-01
• Study Completion: 2022-08-01
• Status Verified: 2022-09
• Study First Submitted: 2022-09-28
• Study First Submitted QC: 2022-09-28
• Last Update Submitted: 2022-09-28
• Study First Posted: 2022-10-03
• Last Update Posted: 2022-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Subjects age 18 and older
2. Diagnosis of COPD or an interstitial lung disease

Exclusion Criteria

Pregnant subjects, subjects with an active cancer diagnosis except for basal cell skin cancer-

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pulmonary Lung Function	3 months	Lung function will be measured with spirometry to test FVC volume, FVC % predicted, FEV1 volume, and FEV1% predicted.

Secondary Outcome Measures

Name	Time	Method
Quality of Life subjective	3 and 12 months	Quality of life will be measured with the Clinical COPD Questionnaire (CCQ).

Trial Locations

Locations (1)

Centers for Respiratory Health; 🇺🇸 Tampa, Florida, United States