COPD ILDPRP-PCNCT05562843
Autologous Cellular Therapy With PRP-PC in Chronic Lung Diseases: An Observational Study LI-004
An observational study of COPD ILD, run by H-CYTE at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD ILD
- What is being tested?
- Autologous Cellular Therapy with PRP-PC
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2021to 1 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Conventional treatment for chronic lung disease typically involves inhaled bronchodilators, steroids, oxygen therapy, antifibrotic medications, lung reduction surgery and lung transplantation for the management of symptoms, although none of these modalities (aside from surgery/transplant) thwarts long-term progression of the disease.. With transplantation the availability of donor lungs is scarce and the longterm need for anti-rejection medication and monitoring can be overwhelming. Recent advances in the field of regenerative medicine in lung disease have demonstrated that autologous cellular therapy may reduce inflammation and aid in the maintenance and repair of damaged lung tissue
Who may be able to join
- Subjects age 18 and older
- Diagnosis of COPD or an interstitial lung disease
Who cannot join
- Pregnant subjects, subjects with an active cancer diagnosis except for basal cell skin cancer-
Trial locations and contacts
1 site in 1 country.
United States1 site
Centers for Respiratory Health
Tampa, Florida, 33602
About this study
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.
Read the 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
- Being tested
- Autologous Cellular Therapy with PRP-PC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Cellular Therapy with PRP-PCBiological
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary Lung Function
Lung function will be measured with spirometry to test FVC volume, FVC % predicted, FEV1 volume, and FEV1% predicted.
Measured: 3 months
Secondary outcomes (1)
Quality of Life subjective
Quality of life will be measured with the Clinical COPD Questionnaire (CCQ).
Measured: 3 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start10 Jun 2021
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD ILDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- H-CYTE
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05562843
- Sponsor's protocol ID
- HCYTE LI-004
- Acronym
- PRP-PC
- Status last verified
- Sep 2022
- First submitted
- 28 Sep 2022
- Last updated
- 3 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Cellular Therapy With PRP-PC in Chronic Lung Diseases: An Observational Study LI-004
- ClinicalTrials.gov ID
- NCT05562843
- Acronym / sponsor ID
- PRP-PC / HCYTE LI-004
- Conditions
- COPD ILD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- H-CYTEIndustry (pharma, biotech, devices)
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 3 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Conventional treatment for chronic lung disease typically involves inhaled bronchodilators, steroids, oxygen therapy, antifibrotic medications, lung reduction surgery and lung transplantation for the management of symptoms, although none of these modalities (aside from surgery/transplant) thwarts long-term progression of the disease.. With transplantation the availability of donor lungs is scarce and the longterm need for anti-rejection medication and monitoring can be overwhelming. Recent advances in the field of regenerative medicine in lung disease have demonstrated that autologous cellular therapy may reduce inflammation and aid in the maintenance and repair of damaged lung tissue
Key inclusion criteria (2 listed)
- Subjects age 18 and older
- Diagnosis of COPD or an interstitial lung disease
Key exclusion criteria (1 listed)
- Pregnant subjects, subjects with an active cancer diagnosis except for basal cell skin cancer-
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Cellular Therapy with PRP-PCIn 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. | Biological | – |
Primary outcome
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.
1 secondary outcome
Quality of Life subjective
Time frame: 3 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD ILD, run by H-CYTE at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary Lung Function (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2022.