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OpenTrials
Completed

NCT Number: NCT05562843

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centers for Respiratory Health

Tampa, Florida, 33602, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects age 18 and older
  • Diagnosis of COPD or an interstitial lung disease

Exclusion criteria

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

Treatment and study plan

Autologous Cellular Therapy with PRP-PC

Biological

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.

Primary outcomes

  1. Pulmonary Lung Function

    Time frame: 3 months

    Lung function will be measured with spirometry to test FVC volume, FVC % predicted, FEV1 volume, and FEV1% predicted.

Secondary outcomes

  1. Quality of Life subjective

    Time frame: 3 and 12 months

    Quality of life will be measured with the Clinical COPD Questionnaire (CCQ).

Sponsors and collaborators

Lead sponsor

H-CYTE

Industry

Registry information

Acronym: PRP-PC

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 3, 2022
Registry last updated
Oct 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.