Advancing JadiCell™ Through Evidence-Based Development
JadiCell™ is an investigational allogeneic umbilical cord-derived mesenchymal cell platform being developed for severe inflammatory pulmonary disease.
A Translational Clinical Development Program
The JadiCell™ clinical development program builds from published randomized clinical experience in COVID-19-associated ARDS toward continued investigation in broader severe pulmonary disease.
Published Phase 1/2a Study
Randomized, controlled clinical evaluation of umbilical cord-derived mesenchymal cells in patients with COVID-19-associated ARDS.
Biomarker Investigation
Exploratory clinical research evaluated circulating inflammatory mediators and pharmacodynamic signals associated with treatment.
Phase 3 ARDS Program
A registered controlled Phase 3 study has been designed to further investigate JadiCell™ in patients with moderate-to-severe ARDS.
Clinical Development Perspective: Early clinical findings provide a basis for continued investigation, but results from COVID-19-associated ARDS should not be assumed to establish safety or efficacy in non-COVID ARDS, COPD, or other diseases.
From Early Human Evidence to Late-Stage Evaluation
Breathe Biologics is advancing JadiCell™ through a staged clinical-development strategy integrating published human evidence, translational learning, regulatory development, and further controlled clinical evaluation.
Phase 1/2a Clinical Research
Randomized controlled research in COVID-19-associated ARDS provides published human safety, clinical, and biomarker observations supporting continued investigation.
Biomarkers & Pharmacodynamics
Translational analyses explore inflammatory signaling, pharmacodynamic response, soluble receptor biology, and potential relationships between biological activity and clinical outcomes.
Phase 3 ARDS Program
Continued clinical development is designed to evaluate JadiCell™ in a larger randomized controlled setting in moderate-to-severe Acute Respiratory Distress Syndrome.
Evidence Generation
Future development will depend on controlled clinical data, regulatory feedback, safety findings, translational evidence, manufacturing readiness, and program-specific scientific considerations.
Clinical advancement is guided by a progression from disease biology and mechanistic rationale through translational evidence and appropriately controlled human clinical investigation.
Phase 1/2a Randomized Controlled Study
Published research evaluated umbilical cord-derived mesenchymal cells in a randomized, placebo-controlled study involving patients with COVID-19-associated ARDS.
Increased
Reduced
Evidence Qualification: These findings were exploratory and derived from a small clinical study in COVID-19-associated ARDS. They should not be extrapolated to broader ARDS populations or interpreted as establishing clinical efficacy.
Phase 1/2a Safety Experience
Safety findings from the published randomized study provide early clinical experience with intravenous administration of the investigational cellular product.
- No serious adverse events were attributed to the infusions.
- No reported difference in infusion-associated adverse events versus control.
- No signal of acute infusion-related cardiac toxicity was reported.
Interpretation: The available experience is limited by the small number of treated patients. Rare, delayed, or population-specific risks cannot be excluded and require continued investigation in larger controlled studies.
Clinical Investigation of JadiCell™
Clinical development includes a completed randomized Phase 1/2a study in COVID-19-associated ARDS and a registered Phase 3 study designed to evaluate JadiCell™ in moderate-to-severe ARDS.
Proportion of patients alive and free of respiratory failure at Day 60 following randomization.
- All-cause mortality at Day 60
- Day 31 survival
- Day 31 serious adverse events
- Serious-adverse-event-free survival
- Time to clinical recovery through Day 60
- Time to oxygen requirement ≤ 40%
Clinical Trial Information: Trial protocols, endpoints, enrollment status, locations, and timelines may change. Current trial information should be confirmed against the applicable ClinicalTrials.gov registration before external publication. Holding an IND permits investigational clinical testing and does not constitute regulatory approval of JadiCell™ for any indication.
