Ignite Creation Date:
2024-05-06 @ 6:09 PM
Last Modification Date:
2024-10-26 @ 2:42 PM
Study NCT ID:
NCT05562843
Status:
COMPLETED
Last Update Posted:
2022-10-03
First Post:
2022-09-28
Brief Title:
Autologous Cellular Therapy With PRP-PC in Chronic Lung Diseases An Observational Study LI-004
Sponsor:
H-CYTE
Organization:
H-CYTE
Study Overview
Official Title:
Autologous Cellular Therapy With PRP-PC in Chronic Lung Diseases An Observational Study LI-004
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRP-PC
Brief Summary:
For this study cells will be harvested from the patient from the peripheral blood isolated and concentrated using proprietary Emcyte equipmentcentrifugation 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 lungs 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 Objectives 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None