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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05562843
Acronym
PRP-PC
Enrollment
150
Registered
2022-10-03
Start date
2021-06-10
Completion date
2022-08-01
Last updated
2022-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD ILD

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

Interventions

BIOLOGICALAutologous 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.

Sponsors

H-CYTE
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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-

Design outcomes

Primary

MeasureTime frameDescription
Pulmonary Lung Function3 monthsLung function will be measured with spirometry to test FVC volume, FVC % predicted, FEV1 volume, and FEV1% predicted.

Secondary

MeasureTime frameDescription
Quality of Life subjective3 and 12 monthsQuality of life will be measured with the Clinical COPD Questionnaire (CCQ).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026