JadiCell: A Clinical Breakthrough in Treating ARDS

Transforming Hope Into Healing

A groundbreaking Phase 1/2a double-blind, randomized, placebo-controlled trial conducted at the University of Miami Health System / Jackson Memorial Hospital has demonstrated the safety and remarkable therapeutic potential of JadiCell umbilical-cord-derived mesenchymal stem cells in patients suffering from COVID-19–induced Acute Respiratory Distress Syndrome (ARDS).

Published in Stem Cells Translational Medicine (Wiley, 2021)
ClinicalTrials.gov Identifier: NCT04355728

Study Snapshot

Parameter

Details

Study Type

Double-blind, randomized, placebo-controlled

Participants

24 hospitalized ARDS patients (12 treated, 12 control)

Treatment

Two IV infusions of 100 ± 20 million JadiCells, 72 hours apart

Manufacturing

Conducted under cGMP standards at the Diabetes Research Institute

Cell Origin

Subepithelial lining of umbilical cord (provided by JadiCell, U.S. Patent 9,803,176 B2)

Exceptional Safety Profile

  • No serious adverse events linked to JadiCell infusions
  • No infusion reactions, cardiac events, or deaths within 24 hours
  • Well tolerated by even the most critically ill ARDS patients

“UC-MSC infusions were safe and showed no treatment-related adverse events.”
— STEM CELLS Translational Medicine (2021)

Clinical Outcomes That Speak Volumes

Outcome

JadiCell Group

Control Group

Statistical Significance

Survival Rate (31 days)

91%

42%

P = 0.015

Serious Adverse Events

2 cases

16 cases

P = 0.008

Time to Recovery

Significantly shorter

—

P = 0.03

Survival improved by more than double in patients receiving JadiCell therapy.

Stopping the Cytokine Storm

JadiCell treatment caused a dramatic decrease in inflammatory cytokines driving ARDS severity — including:
IL-6, TNF-α, IFN-γ, GM-CSF, PDGF-BB, and RANTES.
These findings confirm JadiCell’s immunomodulatory mechanism, helping the body rebalance its immune response and heal damaged lung tissue.

“Inflammatory cytokine concentrations showed marked and statistically significant decreases from Day 0 to Day 6 only in the JadiCell group.”
— STEM CELLS Translational Medicine (2021)

How JadiCell Works

  1. Calms Inflammation

Suppresses the hyperinflammatory “cytokine storm” responsible for tissue destruction in ARDS.

  1. Repairs Lung Tissue

Promotes regeneration of the alveolar-capillary interface and restoration of oxygen exchange.

  1. Restores Immune Balance

Reduces excessive immune activation while supporting protective immune functions.

  1. Improves Survival and Recovery

Patients treated with JadiCells recovered faster, with fewer complications and markedly higher survival.

Why It Matters

This was the first randomized, controlled trial to demonstrate a statistically significant survival benefit in ARDS using stem cell therapy.
The results open new therapeutic frontiers for:

  • Trauma-related ARDS
  • Sepsis-induced lung injury
  • Pneumonia and viral respiratory failure

“These findings strongly support further investigation in larger multicenter trials to establish efficacy.”
— STEM CELLS Translational Medicine (2021)

Summary

“JadiCell therapy in COVID-19 ARDS is safe and associated with significant reductions in mortality, serious adverse events, and recovery time — accompanied by a profound decline in inflammatory cytokines.”
— STEM CELLS Translational Medicine (2021)

Publication & Acknowledgments

  • Title: Umbilical Cord Mesenchymal Stem Cells for COVID-19 ARDS: A Double-Blind, Randomized, Controlled Trial
  • Journal: STEM CELLS Translational Medicine (Wiley, 2021)
  • Principal Investigator: Dr. Camillo Ricordi, M.D.
  • Funding: The Cure Alliance, North America’s Building Trades Unions (NABTU), Barilla Group & Family, Simkins Family Foundation
  • Cell Source: Provided by JadiCell – U.S. Patent 9,803,176 B2