JadiCell™
A patented, investigational, allogeneic mesenchymal cell platform derived from the subepithelial layer of umbilical cord tissue and being developed for severe inflammatory and degenerative pulmonary disease.
A Distinct Umbilical Cord-Derived MSC Platform
JadiCell™ is a patented, investigational, allogeneic mesenchymal cell (MSC) platform derived from the subepithelial layer of umbilical cord tissue. Unlike many MSC products that are isolated from Wharton's jelly, bone marrow, or adipose tissue, JadiCell is manufactured from a distinct anatomical region of the umbilical cord using proprietary methods described in its patent portfolio.
The platform is being developed by Breathe Biologics for severe inflammatory and degenerative pulmonary diseases. Current clinical development includes Phase 3 evaluation in Acute Respiratory Distress Syndrome (ARDS) and an active Investigational New Drug (IND) application supporting development in Chronic Obstructive Pulmonary Disease (COPD).
Rather than replacing damaged lung tissue through engraftment, JadiCell is designed to exert its biological activity primarily through paracrine signaling, immune modulation, secretion of regenerative mediators, and restoration of tissue homeostasis.
Published clinical research has demonstrated encouraging safety findings together with biomarker changes consistent with immunomodulatory activity in patients with COVID-19-associated ARDS, although larger confirmatory trials are required to establish efficacy.
A Distinctive Mesenchymal Stromal Cell Profile
JadiCell™ belongs to the broader family of mesenchymal stromal cells (MSCs) but possesses a distinctive biological profile related to its neonatal tissue source and proprietary isolation methodology.
Cells demonstrate the characteristic spindle-shaped fibroblast morphology typical of MSC populations while expressing surface-marker profiles consistent with mesenchymal cell identity.
At Least 8 Positive Biomarkers
Positive biomarkers reported within the JadiCell™ mesenchymal stromal cell profile include:
- CD29
- CD73
- CD90
- CD166
- SSEA4
- CD9
- CD44
- CD146
- CD105
At Least 8 Negative Biomarkers
Negative biomarkers reported within the hematopoietic profile include:
- CD45
- CD34
- CD14
- CD79
- CD106
- CD86
- CDS0
- CD80
- CD19
- CD117
- Stro-1
- HLA-DR
Neonatal Tissue Source
JadiCell™ is derived from the subepithelial region of qualified umbilical cord tissue rather than adult bone marrow or adipose tissue.
Allogeneic Platform
The platform is intended for standardized donor-derived manufacturing rather than individualized patient-specific production.
Dynamic Cellular Activity
As a living cellular therapy, JadiCell™ may alter its secretory profile in response to biological signals within inflammatory microenvironments.
Scientific qualification: These mechanisms remain areas of active investigation and should not be interpreted as established clinical effects of JadiCell™.
Multipotent Cellular Characteristics
JadiCell demonstrates the multipotent differentiation characteristics expected of mesenchymal stromal cells while maintaining substantial proliferative capacity during manufacturing.
Osteogenic
Chondrogenic
Adipogenic
Therapeutic Development Is Not Based on Tissue Replacement
Although differentiation capabilities help confirm MSC identity, current therapeutic development is not based on direct tissue replacement.
Instead, accumulating evidence indicates that biological activity is primarily associated with secreted mediators and immunomodulatory signaling.
Designed for Large-Scale Allogeneic Manufacturing
One of JadiCell's distinguishing characteristics is its potential suitability for large-scale allogeneic manufacturing.
Beginning with carefully screened umbilical cord tissue donors, cells are expanded under controlled Good Manufacturing Practice (GMP) conditions to generate standardized clinical product.
The allogeneic manufacturing model has the potential to generate numerous standardized treatment doses from a qualified donor-derived starting population, supporting scalability while avoiding patient-specific manufacturing.
From Qualified Donor Tissue to Clinical Distribution
A controlled manufacturing pathway designed to support reproducibility, product characterization, quality control, cryopreservation, and scalable distribution.
Product Characterization & Release Testing
Manufacturing incorporates extensive release testing intended to support product identity, quality, safety, reproducibility, and suitability for clinical use.
Supporting an Allogeneic Development Model
Published laboratory work has reported manufacturing characteristics relevant to continued development and potential scalability of the JadiCell™ platform.
Proliferative Capacity
Published work has reported extended proliferative capacity, including more than 90 population doublings under reported laboratory conditions.
Stable Morphology
Reported studies describe maintenance of characteristic cellular morphology during prolonged culture and expansion.
Genetic Stability
Published laboratory studies have reported maintenance of a normal chromosomal karyotype during prolonged culture under the reported experimental conditions.
One Qualified Starting Population, Multiple Standardized Doses
The allogeneic manufacturing model has the potential to generate numerous standardized clinical doses from a qualified donor-derived starting population.
This model is intended to support scalability while avoiding the individualized manufacturing requirements associated with patient-specific autologous cellular therapies.
Manufacturing qualification: This section describes the general manufacturing framework and published characteristics associated with the JadiCell™ platform. Final clinical manufacturing processes, specifications, assays, acceptance criteria, release requirements, and product controls are governed by applicable controlled manufacturing and regulatory documentation.
Proprietary Platform Protection
JadiCell is supported by a proprietary intellectual property portfolio centered on U.S. Patent No. 9,803,176 B2.
The patent describes mesenchymal cells isolated from the subepithelial layer of umbilical cord tissue, along with methods for their isolation, expansion, characterization, and therapeutic use.
The intellectual property differentiates JadiCell from many MSC platforms that utilize alternative tissue sources such as bone marrow, adipose tissue, Wharton's jelly, placenta, dental pulp, or peripheral blood.
Important: Patent protection does not establish clinical efficacy or regulatory approval. Clinical benefit must ultimately be demonstrated through adequately controlled clinical trials.