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

• Sponsor: H-CYTE (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05562843
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Actual Duration (Months): 13.7
• Patients Per Site Per Month: 10.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COPD ILD	Biological: Autologous Cellular Therapy with PRP-PC

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

• Study Type: Observational
• Actual Enrollment: 150 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Autologous Cellular Therapy With PRP-PC in Chronic Lung Diseases: An Observational Study LI-004
• Actual Study Start Date: Jun 10, 2021
• Actual Primary Completion Date: Aug 1, 2022
• Actual Study Completion Date: Aug 1, 2022

Outcome Measures

Primary Outcome Measures

1. 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

1. Quality of Life subjective [3 and 12 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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-

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centers for Respiratory Health	Tampa	Florida	United States	33602

Sponsors and Collaborators

• H-CYTE

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: H-CYTE
• ClinicalTrials.gov Identifier: NCT05562843
• Other Study ID Numbers: HCYTE LI-004
• First Posted: Oct 3, 2022
• Last Update Posted: Oct 3, 2022
• Last Verified: Sep 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lung Diseases

Study Results

No Results Posted as of Oct 3, 2022