Advancing Regenerative Immunology
for Severe Respiratory Disease
Breathe Biologics is developing investigational regenerative immunotherapies designed to address immune dysregulation and tissue injury in severe respiratory disease. Allogeneic UC-MSC cellular therapy targeting severe inflammatory & fibrotic pulmonary disease — with human Phase 1/2a clinical evidence
JadiCell™'s proposed mechanisms of action, organized by functional category. Evidence level is indicated for each.
Immune Modulation
Suppression of pro-inflammatory cytokine signaling (TNFα, IL-6, IL-1β).
Preclinical & TranslationalCytokine Control
Modulation of inflammatory cytokine cascades implicated in ARDS pathophysiology.
Preclinical EvidenceEndothelial Repair
Support for endothelial barrier stabilization to limit vascular leak.
Preclinical / MechanisticEpithelial Repair
Support for alveolar epithelial repair processes.
Preclinical / MechanisticAlveolar Fluid Clearance
Proposed support for alveolar fluid clearance mechanisms.
Preclinical / MechanisticRemodeling Control
Anti-fibrotic paracrine signaling relevant to tissue remodeling.
Preclinical EvidenceNCT04355728. Results below reflect this single published trial and should not be extrapolated to other ARDS etiologies or pipeline indications.
Source: Lanzoni et al., STEM CELLS Translational Medicine (2021). View the publication .
View the registered study on ClinicalTrials.gov →
Registered Phase 3 study evaluating JadiCell™ in patients with moderate-to-severe ARDS.
| Primary Endpoint | Proportion of patients alive and free of respiratory failure at Day 60 following randomization. |
| Key Secondary Endpoint | All-cause mortality at Day 60. |
| Other Endpoints | Survival at Day 31; incidence of serious adverse events through Day 31; serious-adverse-event-free survival; time to clinical recovery through Day 60. |
| Treatment | Two IV infusions, administered Day 0 and Day 3. |
| Enrollment | 128 planned subjects. |
Status: IND open, trial initiation underway. Enrollment has not yet begun. Endpoint descriptions reflect the currently registered study design and should be updated if the protocol or ClinicalTrials.gov registration is amended.
JadiCell™ is being advanced beyond ARDS as a platform for additional severe respiratory diseases.
A controlled manufacturing framework designed to support identity, consistency, release testing, cryopreservation, and clinical distribution.
A diligence-oriented resource center separating published clinical findings, mechanistic research, biomarker hypotheses, and intellectual property.
Breathe Biologics welcomes confidential discussions with pharmaceutical, biotechnology, and investment organizations evaluating regenerative immunology and severe respiratory disease opportunities.
Start a Confidential Discussion →Scientific Note: JadiCell™ remains investigational. Published clinical findings cited on this site derive from a Phase 1/2a randomized controlled study in COVID-19-associated ARDS. Mechanistic hypotheses and potential additional indications require prospective validation.
View Scientific & Regulatory Information →Clinical evidence referenced throughout this page derives from a single published Phase 1/2a randomized controlled trial in COVID-19-associated ARDS (NCT04355728; Lanzoni et al., STEM CELLS Translational Medicine) and should not be interpreted as demonstrated efficacy across all ARDS etiologies or other pipeline indications. Mechanism-of-action statements not attributed to this trial reflect preclinical or mechanistic evidence and have not been clinically confirmed for JadiCell™ in humans. Phase 3 (ARDS, NCT07479043) refers to an open IND with trial initiation underway; enrollment has not yet begun. The registered Phase 3 primary endpoint is the proportion of patients alive and free of respiratory failure at Day 60 following randomization; all-cause mortality at Day 60 is a key secondary endpoint, along with Day 31 survival and Day 31 serious-adverse-event measures. COPD, Pulmonary Fibrosis / ILD, Bronchiectasis, and Pulmonary Vascular Disease are potential future indications and do not yet have an active IND. Regulatory designations, trial identifiers, and endpoint descriptions should be confirmed against current FDA/ClinicalTrials.gov records before external publication, and updated if the protocol or registration is amended.
A Differentiated Investigational
Regenerative Cell Therapy Platform
JadiCell™ is an investigational allogeneic umbilical cord tissue-derived mesenchymal cell platform designed to modulate immune responses while supporting tissue repair. Its biological characteristics, manufacturing strategy, and clinical development program distinguish it from conventional autologous and adult-derived cell therapies.