Platelet-based Therapy May Slow Lung Function Decline
Treatment with PRP-PC, an investigational platelet-based cellular therapy, may slow the decline in lung function typically experienced by people with chronic obstructive pulmonary disease (COPD), a new study with real-world data indicates.
With this therapy, being developed by H-CYTE, a person’s own blood is treated in the lab and then infused back into the patient, with a goal of lessening inflammation.
The study’s findings provide “clinically significant real-world data … aimed at improving lung health,” Robert Greif, CEO of H-CYTE, said in a press release.
The study, “Longitudinal Assessment of FEV1 Change Following Autologous Cellular Therapy,” was published in the Journal of Regenerative Medicine and Biology Research.
PRP-PC, short for platelet-rich plasma-platelet concentrate, is an autologous cellular therapy, meaning it’s made from blood collected from the patient being treated. The blood is concentrated for certain cellular components and then infused back into the patient.
The main components in PRP-PC are platelets — small cellular fragments that help coordinate blood clotting and wound healing, among other processes — and certain white blood cells. In the context of COPD, the therapy is designed to lessen inflammation and promote healing in the lungs, which become damaged over time.
The new study reports on 281 people with COPD who underwent treatment with PRP-PC at the Lung Health Institute, in Texas, which is operated by H-CYTE.
More than half (60%) of the participants were male, with a mean age in the early 70s. Before and after treatment, all participants underwent FEV1 testing, a measure of how much air a person can exhale in one second — commonly used to assess lung function.
The study comprised two participant groups: A, whose 150 patients were assessed three months after treatment with PRP-PC, and group B, which included the remaining 131 participants, assessed at least one year after being given the platelet-based therapy. The mean time from treatment to assessment was 19.5 months.
In group A, the mean FEV1 before treatment was 33.2%. By three months after treatment, this value increased to 34.7%. In group B, mean FEV1 improved from 35.8% before treatment, to 38.1% when re-evaluated more than one year later.
Statistical analyses suggested it was unlikely these improvements were due to random chance. Also noteworthy is that, usually, people with COPD experience a decrease in FEV1 over time, which contrasts with these findings.
“These findings are particularly important because they suggest that this therapy may help slow or prevent the typical, expected progression of COPD,” said Melissa Rubio, PhD, a researcher at Lung Health Institute and sole author of the study.
Additional analyses showed that 23.3% of participants in group A had an increase of at least 15% in FEV1 at three months post-treatment. The proportion of patients in group B with such an increase in FEV1 at more than a year post-treatment was 29%.
Moreover, about two-thirds of participants in both groups reported clinically meaningful improvements in quality of life after treatment.
“On average, participants undergoing autologous cellular therapy with PRP-PC experienced a statistically and clinically significant increase in lung function after both 3 months and after at least one year … along with a significant improvement in subjective quality of life,” Rubio wrote.
PRP-PC treatment was generally considered safe and well-tolerated, with no adverse or unexpected events reported.
A noted limitation of this study was that it was observational and lacked a proper control group. Yet, due to the serious nature of COPD, the use of a placebo in this study was considered unethical, the researcher said.
“Due to the chronicity and often end-stage nature of the disease being studied here, we did not find it ethical to give placebo to a sub-group of participants therefore no participants in this study received comparative placebo,” Rubio wrote.
However, such studies are needed, she said.
“Further research should include a head-to-head comparison with standard of care and the use of matched controls,” Rubio wrote.
To build on these findings, H-CYTE is currently planning a clinical trial to further test the experimental therapy.
“With the publishing of this peer reviewed study, we gain tangible data, strengthening the underlying foundation of our current operations, while allowing us to better compose and execute our strategy going forward,” Greif said.