Key findings
- Cytora Therapeutics, Made Scientific, and Zeo ScientifiX are partnering to manufacture and commercialize Cytora’s oral mucosal stem cell therapy in the US.
- The group plans to commercialize first in Florida under SB 1768, while also preparing a Phase 2b FDA clinical trial pathway.
- Cytora says its Phase 1/2a diabetic foot ulcer study showed a favorable safety profile and statistically significant wound area reduction vs placebo.
Cytora Therapeutics Ltd., Made Scientific, Inc., and Zeo ScientifiX, Inc. have formed a partnership to advance and commercialize Cytora’s allogeneic (donor-derived), off-the-shelf human oral mucosal stem cell therapy in the United States. The initial focus is non-healing diabetic foot ulcers (DFUs), with the companies also pointing to potential expansion into other wound care, pain, and orthopedic indications.
What Cytora is developing
Cytora’s platform is based on proprietary allogeneic human oral mucosal stem cells (hOMSCs). Cytora says oral mucosal stem cells can be collected through minimally invasive procedures and have characteristics that support tissue regeneration and wound healing.
Clinical data (Previous Phase 1/2a Trial)
In April 2025, Cytora announced positive results of its Phase 1/2a randomized, placebo-controlled trial in diabetic foot ulcers in which hOMSC200 “demonstrated a favorable safety profile,” with no serious adverse events related to treatment, according to an independent Data Safety Monitoring Board (DSMB).
The company reported:
- Statistically significant superiority over placebo in wound surface area reduction.
- Complete wound closure in diabetic patients whose ulcers had been open for an average of 27 months.
Two-track plan: Florida commercialization and an FDA trial pathway
The partners say they plan to pursue commercialization under Florida’s Senate Bill 1768 (SB 1768), which provides a pathway for commercialization of adult allogeneic stem cell therapies for certain indications in the state. In parallel, they plan to begin work toward a Phase 2b clinical program under an FDA investigational new drug (IND) pathway, with the stated goal of obtaining an FDA license.
DFUs will be the lead indication, with an estimated 125,000 new DFU patients annually in Florida alone.
Who does what
Under the agreement:
- Cytora will provide the right to manufacture its product while continuing clinical and regulatory development.
- Made Scientific will serve as the exclusive US manufacturing partner, including GMP manufacturing and quality control release testing of starting tissue-derived cell banks and final drug product at its new Princeton, New Jersey facility.
- Zeo will serve as the exclusive US commercial partner, including market access, distribution infrastructure, and clinical site management.
“Zeo has built the regulatory expertise, clinical infrastructure, and physician networks specifically to capitalize on the newly passed Florida’s SB 1768 stem cell law and other legal use of stem cell frameworks,” said Ian Bothwell, CEO and CFO of Zeo ScientifiX. “Partnering with Cytora and Made Scientific allows us to bring a differentiated allogeneic stem cell therapy to the physicians and patients we already serve. This partnership reflects our shared commitment to expanding patient access to transformative cell therapies through responsible, compliant commercialization.”
Company snapshots
Made Scientific is a US-based cell therapy contract development and manufacturing organization (CDMO) working on autologous (patient-derived) and allogeneic cell therapy products, operating from two facilities in New Jersey. More information: madescientific.com.
Cytora is an Israeli biopharmaceutical company developing off-the-shelf oral mucosa stem cell therapeutics. The company says it has completed a Phase 1/2a study in DFUs and is conducting a Phase 1 study in multiple system atrophy (MSA). More information: cytorastem.com.
Zeo ScientifiX, Inc. is a clinical-stage biopharmaceutical company focused on research, clinical trials, and manufacturing of biological products, and says its products are compliant with Florida’s new stem cell therapy law. More information: zeoscientifix.com.
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