Human Amniotic Fluid / University of Utah - LARVOL DELTA

Lyophilized Human Amniotic Fluid Ameliorates Myocardial Ischemic Injury (ISHLT 2025) - "hAF and lyohAF treated cells exposed to hypoxia both demonstrated greater cell viability than untreated controls (hAF: 115.8 + 19.3%, lyohAF: 139.3 + 17.3% vs. C: 56.1%, p=0.006).Conclusion LyohAF offers potent myocardial protection from ischemic injury with an efficacy equivalent to what has been previously demonstrated with hAF. LyohAF, however, represents a more accessible, "maneuverable," and broadly applicable modality which may expand its scope of utilization to remote and austere environments wherein hAF use is prohibitive."

Congestive Heart Failure • Heart Failure • Myocardial Ischemia

Intravenous Acellular Human Amniotic Fluid Preserves Cardiac Function Following Permanent Ischemic Injury (ISHLT 2025) - "Functional cardioprotection is mechanistically associated with cellular tolerance to hypoxic insult. Its ubiquitous availability as well as its diverse array of immune-modulating and anti-inflammatory proteins offer promising potential for acellular hAF as a cardioprotective adjunct."

Cardiovascular • Congestive Heart Failure • Coronary Artery Disease • Fibrosis • Heart Failure • Immunology • Myocardial Ischemia • Reperfusion Injury

Proteomic Characterization of Cardioprotective Human Acellular Amniotic Fluid. (PubMed, ACS Omega) - "Human amniotic fluid (hAF) has been used in medical applications such as wound healing, skin disorders, and ophthalmic conditions...In addition, these proteins were highly modified, with methylation and deamidation being the most abundant modifications. This study represents the first mass-spectrometry-based characterization of full-term, acellular hAF, suggesting that hAF offers a wide array of immune-modulating proteins working together to provide robust cardioprotection and a valuable treatment for ischemia-reperfusion injury."

Journal • Cardiovascular • Dermatology • Inflammation • Myocardial Ischemia • Ophthalmology • Reperfusion Injury

PAF for the Treatment of Osteoarthritis (clinicaltrials.gov) - P1/2 | N=60 | Completed | Sponsor: University of Utah | Active, not recruiting ➔ Completed

Trial completion • Immunology • Osteoarthritis • Pain • Rheumatology

pAF for the Treatment of Osteoarthritis (clinicaltrials.gov) - P1/2 | N=60 | Active, not recruiting | Sponsor: University of Utah | Trial completion date: Jul 2025 ➔ Jan 2025 | Trial primary completion date: Jul 2024 ➔ Jan 2025

Trial completion date • Trial primary completion date • Immunology • Osteoarthritis • Pain • Rheumatology

pAF for the Treatment of Osteoarthritis (clinicaltrials.gov) - P1/2 | N=60 | Active, not recruiting | Sponsor: University of Utah | Recruiting ➔ Active, not recruiting

Enrollment closed • Immunology • Osteoarthritis • Pain • Rheumatology

Processed Amniotic Fluid (pAF) for the Treatment of Chronic Wounds (clinicaltrials.gov) - P1/2 | N=1 | Terminated | Sponsor: University of Utah | Completed ➔ Terminated; Enrollment was halted prematurely after enrolling one participant due to difficulty finding eligible participants.

Trial termination

Safety and Feasibility of Amniotic Fluid as a Treatment for COVID-19 Patients (clinicaltrials.gov) - P1/2 | N=47 | Completed | Sponsor: University of Utah | Recruiting ➔ Completed | Trial completion date: Sep 2021 ➔ Feb 2023

Trial completion • Trial completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CRP • IL6

A randomized, double-blinded, placebo-controlled clinical trial of sterile filtered human amniotic fluid for treatment of COVID-19. (PubMed, BMC Infect Dis) - P1/2 | "In this randomized clinical trial involving hospitalized patients with COVID-19, the intravenous administration of 10 cc of hAF daily for 5 days did not result in statistically significant differences in either safety or markers of systemic inflammation compared to placebo, though we did not achieve our enrollment target of 60 patients."

Clinical • Journal • Infectious Disease • Inflammation • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases • CRP • IL6

Processed Amniotic Fluid (pAF) for the Treatment of Chronic Wounds (clinicaltrials.gov) - P1/2 | N=1 | Completed | Sponsor: University of Utah | Active, not recruiting ➔ Completed | Trial completion date: Aug 2025 ➔ Mar 2023 | Trial primary completion date: Aug 2025 ➔ Mar 2023

Trial completion • Trial completion date • Trial primary completion date

pAF for the Treatment of Osteoarthritis (clinicaltrials.gov) - P1/2 | N=60 | Recruiting | Sponsor: University of Utah | Trial completion date: Jul 2022 ➔ Jul 2025 | Trial primary completion date: Mar 2022 ➔ Jul 2024

Trial completion date • Trial primary completion date • Immunology • Osteoarthritis • Pain • Rheumatology

A Pilot Study of Human Amniotic Fluid for COVID19 Associated Respiratory Failure (clinicaltrials.gov) - P1 | N=10 | Completed | Sponsor: University of Utah | Unknown status ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IL6

Processed Amniotic Fluid (pAF) for the Treatment of Chronic Wounds (clinicaltrials.gov) - P1/2 | N=1 | Active, not recruiting | Sponsor: University of Utah | Recruiting ➔ Active, not recruiting | N=60 ➔ 1

Enrollment change • Enrollment closed

Processed Amniotic Fluid (pAF) for the Treatment of Chronic Wounds (clinicaltrials.gov) - P1/2 | N=60 | Recruiting | Sponsor: University of Utah | Not yet recruiting ➔ Recruiting

Enrollment open

Acellular human amniotic fluid protects the ischemic/reperfused rat myocardium. (PubMed, Am J Physiol Heart Circ Physiol) - "These observations spanned across diverse donors and likely result from the mixture of a plethora of naturally produced cytokines, chemokines, and immune-modulating proteins rather than a single, defined mechanistic culprit. The ubiquitous availability of hAF as a cell-free solution further suggests its potential for widespread adoption as a therapy for myocardial ischemia/reperfusion injury."

Journal • Preclinical • Cardiovascular • Fibrosis • Immune Modulation • Immunology • Inflammation • Myocardial Ischemia • Reperfusion Injury

pAF for the Treatment of Osteoarthritis (clinicaltrials.gov) - P1/2; N=60; Recruiting; Sponsor: University of Utah

Clinical • New P1/2 trial • Immunology • Osteoarthritis • Pain • Rheumatology

Safety and Feasibility of Amniotic Fluid as a Treatment for COVID-19 Patients (clinicaltrials.gov) - P1/2; N=60; Recruiting; Sponsor: University of Utah; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease • Novel Coronavirus Disease • CRP

Safety and Feasibility of Amniotic Fluid as a Treatment for COVID-19 Patients (clinicaltrials.gov) - P1/2; N=60; Not yet recruiting; Sponsor: University of Utah

Clinical • New P1/2 trial • Infectious Disease • Novel Coronavirus Disease • CRP

A Pilot Study of Human Amniotic Fluid for COVID19 Associated Respiratory Failure (clinicaltrials.gov) - P1; N=10; Recruiting; Sponsor: University of Utah; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Pilot Study of Human Amniotic Fluid for COVID19 Associated Respiratory Failure (clinicaltrials.gov) - P1; N=10; Not yet recruiting; Sponsor: University of Utah

Clinical • New P1 trial