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

NCT ID: NCT05562843

Last Updated: 2022-10-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-10
• Study Completion Date: 2022-08-01

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

Conditions

COPD ILD

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

Autologous Cellular Therapy with PRP-PC

In this study, cells will be harvested from the patient from the peripheral blood, isolated and concentrated using centrifugation, then returned to the patient same day via the peripheral circulation.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

H-CYTE

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centers for Respiratory Health

Tampa, Florida, United States

Countries

United States

Other Identifiers

HCYTE LI-004

Identifier Type: -

Identifier Source: org_study_id