NCT07479043 Mesenchymal stem cells (Therapeutic Solutions International) Respiratory Distress Syndrome, Acute Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07479043 using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, with Drug & Asset MCP and Company & Deal Intelligence MCP used as the companion asset and sponsor enrichment workflow. Explore PatSnap MCP Servers to reproduce the research sequence inside an AI workflow.
MCP evidence snapshot: 17 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07479043 is a hot trial to watch
Respiratory Distress Syndrome, Acute is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07479043 is notable because it evaluates Mesenchymal stem cells (Therapeutic Solutions International) in a Phase 3 design sponsored by Breathe Biologics Inc.. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | NCT07479043 |
| Official title | To Evaluate the Safety and Potential Therapeutic Activity of JadiCell™, an Investigational Umbilical Cord-Derived Mesenchymal Stem Cell Therapy, in Patients Diagnosed With Acute Respiratory Distress Syndrome (ARDS). |
| Phase / status | Phase 3 / Not yet recruiting |
| Intervention | Mesenchymal stem cells (Therapeutic Solutions International) |
| Sponsor | Breathe Biologics Inc. |
| Geography | Not reported in the indexed record |
| Enrollment | [object Object] |
| Primary endpoint | Proportion of Participants Alive and Free of Respiratory Failure |
| Endpoint time frame | 60 days |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
This study evaluates the safety and potential therapeutic activity of JadiCell™, an investigational umbilical cord-derived mesenchymal stem cell therapy, in patients diagnosed with Acute Respiratory Distress Syndrome (ARDS). JadiCells are administered intravenously and are intended to modulate inflammatory responses and promote tissue repair in injured lung tissue.
Allocation is Randomized, masking is Single, and the intervention model is Factorial Assignment. Planned enrollment of [object Object] participants across Not reported in the indexed record shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.
- Proportion of Participants Alive and Free of Respiratory Failure (60 days) — The proportion of participants who are alive and free of respiratory failure following treatment with UC-MSC therapy.
Readout outlook and evidence gap
The current protocol points to [object Object] as the best available readout proxy. Because this is an active or newly posted study, a trial-specific result citation is not included until a normalized clinical-trial-result record becomes available. That gap is itself operationally important: teams should monitor first result indexing, conference abstracts, protocol amendments and changes to the primary-completion date.
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Asset and sponsor context
Drug & Asset MCP profile: Mesenchymal stem cells (Therapeutic Solutions International) is indexed as No normalized modality returned, with target No normalized target returned, mechanism No normalized mechanism returned, and global highest development status No normalized global status returned.
Company & Deal Intelligence MCP profile: Breathe Biologics Inc. is resolved to a normalized organization record in United States. The organization workflow adds identity, location, portfolio and partnering context where available.
The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can determine whether a positive signal becomes a competitive asset.
White space around this program
- Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
- Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
- Comparator relevance: evidence against the most decision-relevant contemporary standard of care.
- Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
- Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.
What to monitor next
Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter the probability of success before a headline data release.
Bottom line
NCT07479043 provides a focused lens on Respiratory Distress Syndrome, Acute development. Its value will be determined by whether Mesenchymal stem cells (Therapeutic Solutions International) can convert the current Phase 3 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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