Connect with us

Technology

Cytora Reports Successful Results of Phase 1/2a Trial of Stem Cell Treatment for Diabetic Foot Ulcers

Published

2 years ago

on

Cytora’s proprietary oral mucosa stem cells treatment holds potential to be a game changer in the field of stem cell therapy

YOKNEAM, Israel, April 9, 2025 /PRNewswire/ — Cytora, a clinical stage company developing unique stem cell treatments based on human Oral Mucosa Stem Cells (hOMSCs), reported today successful results of a Phase 1/2a clinical trial for treating chronic hard to heal diabetic foot ulcers (DFUs) with its leading allogeneic off-the-shelf cell therapy product, hOMSC200. The study results show that hOMSC200 is safe and did not elicit any immune response in recipients. In addition, hOMSC200 was shown to be significantly more effective than the standard of care procedure in treating DFUs.

“Cytora’s unique patented technology, based on oral mucosa stem cells, holds a potential to be a game changer in the field of stem cell therapy,” stated Prof. Sandu Pitaru, Co-Founder and CTO of Cytora. “We are at the forefront of cell therapy, leveraging a proprietary unique stem cell population discovered in the human oral mucosa. Notably, the embryonic origin of this population is a primordial tissue of the developing embryonic brain. These unique stem cells retain in the adult’s oral mucosa the properties of neural and other stem cell types, making them effective in targeting chronic multifaceted diseases, such as chronic wounds, and neurodegenerative and autoimmune diseases. Our Phase 1/2a clinical trial has demonstrated that the use of this stem cell population in humans is safe and effective in treating hard to heal diabetic foot ulcers.”

“We are extremely pleased and encouraged by the remarkable results we saw in this Phase 1/2a trial,” said Yona Geffen, PhD, CEO of Cytora. “Diabetic foot ulcers are a common complication of diabetes and are extremely difficult to treat, leading to significant morbidity. We are targeting the DFU patient population that do not respond to available treatment options. This study enrolled 21 subjects with a mean wound duration of over 2 years, and our results clearly show that not only is hOMCS200 safe for use, with no recorded adverse events or immunological response to the injected cells, but it is also highly effective. The results of this trial put us on solid footing for applying for an IND during the second half of 2025 that will enable starting a large-scale Phase 2 trial for treating DFUs during 2026.”

The Phase 1/2a trial was a single center, randomized, partially blinded study, comprising two hOMSC200 dose groups (low and high) and one placebo treated group of DFU patients. The study enrolled 21 patients with a mean wound duration of 27 months. Subjects received a single administration of either a high or low dose of hOMSC200 or a placebo and were followed up for 18 months. All subjects also received standard of wound care treatments. The primary end point was safety, including treatment-related adverse events and immunological rejection reactions towards the injected cells. Secondary end points included partial and complete wound closure rate.

Results show no recorded adverse events, and no humoral or cellular immune response elicited by the injected cells. The proportion of complete wound closure was higher in the hOMSC200-treated patients in comparison to placebo in all populations, with no significant difference between the low and high dose groups. In the intent to treat (ITT) analysis, there was a 53% wound closure rate in the treatment group versus a 33% wound closure rate in the placebo group. In the per protocol group, which included 12 patients who adhered to protocol guidelines, there was a 100% success rate, versus a 20% success rate of wound closure in the placebo control group.

About Human Oral Mucosa Stem cells (hOMSCs)1

Cytora’s patented and transformative stem cell platform is based on the discovery of a novel and unique stem cell population in the oral mucosa termed human Oral Mucosa Stem Cells (hOMSC). hOMSCs are a unique population of stem cells originating from the neural crest. In the oral cavity, they mediate rapid wound healing compared to other tissues, promote full tissue regeneration, without scarring, and their activity is not affected by age. In addition, this remarkable pattern of wound healing is negligibly affected by diabetes, which is notorious for impeding wound healing in other locations of the body, primarily in the foot.

Cytora has shown that hOMSCs are easily propagated without losing their unique stem-cell properties – a tiny biopsy of 4x3x2 mm from a healthy donor generates doses for thousands of treatments. These cells combine a high therapeutic potency with an excellent safety profile, and do not elicit immune rejection when transplanted in allogeneic recipients, thus enabling the production of an “off the shelf” stem cell treatment platform for human use.

About Diabetic Foot Ulcers

Diabetic foot ulcers (DFUs) are open sores or wounds that occur in individuals with diabetes, due to poor circulation, neuropathy, and impaired wound healing. They can lead to severe infections, gangrene, and even amputation. Approximately 19% to 34% of individuals with diabetes are expected to develop DFU during their lifetime. Treatments include wound care, infection control, offloading pressure, and improving blood sugar control. Advanced treatments include skin grafts, hyperbaric oxygen therapy, and growth factor therapies. Despite all these treatment options, DFUs remain a significant medical challenge, with a healing rate of only 75%, 17% require amputation. In addition, there is a significant increase in mortality rates among patients with DFUs, surpassing that of diabetes alone. There are approximately 1.2M new DFU patients per year in the US alone, with an average treatment cost of $20,000, and severe cases (resulting in amputations) costing > $40K. The global yearly market is estimated at $7.6 Billion.

About Cytora

Established in 2018, Cytora is a biopharmaceutical company at the forefront of stem cell therapy. Cytora developed a revolutionary technology to produce off-the-shelf (allogeneic) therapeutic doses of human Oral Mucosa Stem Cells to treat challenging diseases, including chronic wounds such as incurable diabetic foot ulcers (DFUs) and degenerative diseases such as Parkinson’s Disease, Multiple System Atrophy (MSA), and Alzheimer’s Disease. The Company successfully completed a Phase 1/2a study for treating DFUs and is currently conducting a Phase 1 study for the treatment of MSA. Cytora’s technology platform is based on the discoveries of Prof. Sandu Pitaru, Faculty of Medicine, School of Dentistry at the Tel Aviv University in Israel, who is also the scientific founder of the Company. For additional information, please visit www.cytorastem.com.

Media contact:

Tsipi Haitovsky
Global Media Liaison
+972-52-598-9892
Tsipihai5@gmail.com

1 Arie I, Pal A, et al., 2024. The Lamina Propria of the Oral Mucosa Harbors a Neural Crest-Like Stem Cell Population Resistant to Hyperglycemia Induced by Diabetes Type II, Medical Research Archives, [online] 12(5). https://doi.org/10.18103/mra.v12i5.5181

 

View original content:https://www.prnewswire.com/news-releases/cytora-reports-successful-results-of-phase-12a-trial-of-stem-cell-treatment-for-diabetic-foot-ulcers-302424359.html

SOURCE Cytora

Related Topics:
Continue Reading

Technology

Oracle Introduces New AI-Powered Ways to Execute Work Across Oracle Fusion Applications

Published

20 minutes ago

on

October 26, 2026

By

Fusion Companion and Fusion Agentic Home help organizations achieve business outcomes by enabling employees to execute work across different AI clients while maintaining enterprise security and control

LAS VEGAS, Oct. 26, 2026 /PRNewswire/ — Oracle AI World — Oracle today announced Oracle Fusion Companion with Oracle Fusion Agentic Home, two new capabilities for Oracle Fusion Cloud Applications that transform how employees get work done. Fusion Companion provides an intelligent layer that understands business objectives and automatically selects and coordinates the appropriate transactions, workflows, approvals, AI agents, and agentic applications needed to execute work and achieve business outcomes. Users no longer need to know which application to navigate, which transaction to execute, which workflow or approval to initiate, or which AI agent to use. Fusion Companion determines how to get the work done while maintaining enterprise security, permissions, and controls. Users can access these capabilities through supported AI tools such as ChatGPT or through Oracle Fusion Agentic Home, the native AI experience within Oracle Fusion Applications.

“AI is changing where enterprise work begins, but organizations need to maintain control over how that work gets done,” said Chris Leone, executive vice president, Applications Development, Oracle. “Fusion Companion enables employees to define business objectives and execute work through the AI tools they already use, while Oracle Fusion provides the business context, execution capabilities, and enterprise controls needed to get that work done. With Fusion Agentic Home, we’re bringing this same intelligence to the millions of people who work in Oracle Fusion Applications every day, giving them a simpler way to execute work, from everyday tasks to complex business processes, without having to navigate multiple applications or understand the underlying workflows and AI agents.”

Fusion Companion enables users to work with Oracle Fusion Applications through supported AI tools such as ChatGPT. As the intelligent layer for Oracle Fusion Applications, Fusion Companion uses enterprise business context, data, and user permissions to understand what users want to accomplish and determine how to get the work done. It automatically selects and coordinates the appropriate transactions, workflows, approvals, AI agents, and agentic applications, whether completing a simple task or executing a complex business process. Fusion Companion can also leverage data and context from other enterprise systems and coordinate authorized actions across those systems, enabling work to be completed across applications while respecting established security, permissions, and controls. With Fusion Companion, organizations will be able to:

Simplify enterprise work: Helps employees achieve business outcomes by identifying the agents, applications, and business processes needed to complete their request.Accelerate business execution: Executes complex business work by coordinating specialized AI agents, business processes, and Fusion Agentic Applications, including Fusion Claw-powered applications that perform deep analysis, planning, simulation, optimization, and long-running execution across large volumes of enterprise data.Increase flexibility in how employees work: Enables users to work with Oracle Fusion Applications through supported AI tools such as ChatGPT and customer- or partner-built AI interfaces, while maintaining access to relevant business context and capabilities.Connect work across enterprise systems: Helps organizations coordinate activities across Oracle Fusion Applications, other cloud applications, enterprise content, data platforms, APIs, services, and third-party agents.Maintain enterprise security and accountability: Helps organizations execute AI-driven work within established identity, permissions, policies, and approval controls while keeping enterprise execution and accountability within Oracle Fusion Applications.

Oracle Fusion Agentic Home, supported by Fusion Companion, is a personalized, AI-native experience that enables users to define business objectives, delegate work to AI agents and agentic applications, and track progress through completion. With Fusion Agentic Home, organizations will be able to:

Simplify the employee experience: Enables users to express business objectives through a personalized, AI-native experience that automatically identifies and executes the appropriate work, without requiring users to navigate applications, initiate workflows, or select individual AI agents.Increase employee productivity: Helps users complete work faster by bringing together the information, AI agents, agentic applications, and business processes needed to achieve their objectives.Resolve business exceptions: Identifies the root causes of business exceptions, determines appropriate corrective actions, and executes authorized resolutions while escalating decisions that require human judgment.Enable governed delegation: Enables employees to delegate work to Oracle Fusion AI agents and agentic applications that execute within established enterprise permissions, policies, and approval controls, allowing employees to focus on business objectives, exceptions, and decisions requiring human judgment.

To learn more about Oracle Fusion Applications, visit www.oracle.com/applications

About Oracle Fusion Cloud Applications
Oracle Fusion Cloud Applications are a complete suite of cloud applications that form the enterprise system of record, spanning finance, HR, supply chain, manufacturing, sales, service, and marketing. The suite includes Oracle Fusion Cloud Enterprise Resource Planning (ERP), Oracle Fusion Cloud Human Capital Management (HCM), Oracle Fusion Cloud Supply Chain & Manufacturing (SCM), and Oracle Fusion Cloud Customer Experience (CX).

Fusion Agentic Applications extend that foundation into a system of outcomes. They can coordinate and execute end-to-end work toward business objectives, and are designed to operate within the policies, controls, and authority each organization defines. With Oracle AI Agent Studio for Fusion Applications, customers and partners can create, extend, and manage these agents and agentic applications combining trusted enterprise data with the security, data governance, and performance needed to operate at scale.

About Oracle
Oracle offers integrated suites of applications plus secure, autonomous infrastructure in the Oracle Cloud. For more information about Oracle (NYSE: ORCL), please visit us at www.oracle.com.

Trademarks
Oracle, Java, MySQL, and NetSuite are registered trademarks of Oracle Corporation. NetSuite was the first cloud company—ushering in the new era of cloud computing.

View original content to download multimedia:https://www.prnewswire.com/news-releases/oracle-introduces-new-ai-powered-ways-to-execute-work-across-oracle-fusion-applications-302919021.html

SOURCE Oracle

Continue Reading

Technology

Oracle Introduces Claw-Powered Fusion Agentic Applications for Customer Experience

Published

20 minutes ago

on

October 26, 2026

By

New Fusion Claw Applications help sales and service teams pursue profitable growth and deliver on customer commitments by continuously adapting and executing complex work with enterprise governance

LAS VEGAS, Oct. 26, 2026 /PRNewswire/ — Oracle AI World — Oracle today announced new Oracle Fusion Claw-powered agentic applications for customer experience. Oracle Fusion Claw is a governed agentic execution runtime that enables Fusion Agentic Applications to reason, compute, adapt, and execute specialist-grade work, including deep research, computation, simulation, modeling, and continuous replanning. Built into Oracle Fusion Cloud Applications, the new Claw-powered agentic applications help organizations take on complex, high-value work more autonomously at scale, within established governance controls, from aligning sales territories with growth opportunities and improving customer service journeys to addressing field service demand while controlling overtime costs and protecting quote accuracy as CPQ configurations change.

“Business leaders need to turn growth strategies into opportunities and deliver on customer commitments, but connecting customer demand with enterprise capacity in time to act remains a challenge,” said Kartik Raghavan, senior vice president, Applications Development, Oracle. “With Claw-powered Fusion Agentic Applications for CX, organizations can connect customer needs with the enterprise resources and governed actions required to address them. The applications can reason across trusted Oracle Fusion Applications data, coordinate the work required to meet business objectives, and carry approved actions into execution. This enables organizations to translate business objectives into growth opportunities, reliable service, and stronger customer trust.”

Agentic Applications represent a new class of outcome-based applications that provide Fusion Applications customers with a system of outcomes, where people define the objectives, authority, and accountability and the Agentic Applications coordinate the process to get to an outcome within those parameters. Fusion Claw enables Agentic Applications to take on more complex, specialist-grade work by providing a new execution runtime that supports larger scale and longer-running work, continuous replanning, deterministic execution, and governed automation within organizational policies and controls.

Running on Oracle Cloud Infrastructure, powered by industry-leading LLMs, and extending the world’s most complete suite of cloud applications, the new Fusion Agentic Applications move beyond assistance to governed execution, helping organizations to improve business outcomes while maintaining established oversight and approvals. New Fusion Agentic Applications available within Oracle Fusion Cloud Customer Experience (CX) include:

Account Territory Growth Plan: Models and compares scenarios across different territory configurations, evaluates tradeoffs, and optimizes coverage and opportunity allocation within capacity and business constraints before taking authorized action.Service Health Check: Identifies emerging service-performance issues, determines likely root causes, and prepares high-impact actions across knowledge, automation, routing, policy, and process for review and then executes approved actions before these issues become sustained customer or operational problems.Strategic Field Demand Planning: Aligns field capacity with customer demand while managing overtime costs by predicting resource needs, identifying coverage gaps, and preparing resource actions for review before executing approved changes.CPQ Test-to-Production Setup & Configuration Migration: Prepares and migrates configuration changes to production by assembling a migration package’s declared changes and dependencies in a reviewable report, identifying potential issues before deployment, and executing approved migration steps within provided authority.Executive Briefing Document: Facilitates more effective executive meetings by researching account engagement, company news, product footprint, revenue potential, and organizational hierarchy, then assembling an editable, meeting-ready briefing that it can update as account data changes.

The new Claw-powered Fusion Agentic Applications are part of a broader Fusion AI ecosystem anchored by Oracle AI Agent Studio for Fusion Applications. With the Fusion Agentic Applications Builder and AI Studio Skill no-code and pro-code capabilities in Oracle AI Agent Studio, organizations can create and manage agentic applications using reusable Oracle, partner, and external agents. In addition, built-in observability, ROI measurement, and safety controls enable agents to deliver measurable value and operate at scale within approved authority.

To learn more about Oracle Fusion Applications, visit www.oracle.com/applications

About Oracle Fusion Cloud Applications
Oracle Fusion Cloud Applications are a complete suite of cloud applications that form the enterprise system of record, spanning finance, HR, supply chain, manufacturing, sales, service, and marketing. The suite includes Oracle Fusion Cloud Enterprise Resource Planning (ERP), Oracle Fusion Cloud Human Capital Management (HCM), Oracle Fusion Cloud Supply Chain & Manufacturing (SCM), and Oracle Fusion Cloud Customer Experience (CX).

Fusion Agentic Applications extend that foundation into a system of outcomes. They can coordinate and execute end-to-end work toward business objectives, and are designed to operate within the policies, controls, and authority each organization defines. With Oracle AI Agent Studio for Fusion Applications, customers and partners can create, extend, and manage these agents and agentic applications combining trusted enterprise data with the security, data governance, and performance needed to operate at scale.

About Oracle
Oracle offers integrated suites of applications plus secure, autonomous infrastructure in the Oracle Cloud. For more information about Oracle (NYSE: ORCL), please visit us at www.oracle.com.

Trademarks
Oracle, Java, MySQL, and NetSuite are registered trademarks of Oracle Corporation. NetSuite was the first cloud company—ushering in the new era of cloud computing.

 

View original content to download multimedia:https://www.prnewswire.com/news-releases/oracle-introduces-claw-powered-fusion-agentic-applications-for-customer-experience-302919007.html

SOURCE Oracle

Continue Reading

Technology

Oracle Introduces Claw-Powered Fusion Agentic Applications for Supply Chain

Published

20 minutes ago

on

October 26, 2026

By

New Fusion Claw applications help supply chain teams achieve critical business outcomes with greater speed and confidence by continuously adapting and executing complex work

LAS VEGAS, Oct. 26, 2026 /PRNewswire/ — Oracle AI World — Oracle today announced new Fusion Claw-powered agentic applications for supply chain operations. Oracle Fusion Claw is a governed agentic execution runtime that enables Fusion Agentic Applications to reason, compute, adapt, and execute specialist-grade work including deep research, computation, simulation, modeling, and continuous replanning. Built into Oracle Fusion Cloud Applications, the new Claw-powered agentic applications help organizations take on complex, high-value work more autonomously at scale, within established permissions, from optimizing supply and transportation plans to analyzing procurement spend.

“As supply chain conditions shift, leaders need a connected view across product, planning, procurement, logistics, and cost to make faster, better-informed decisions,” said S.Y. Shenoy, senior vice president, Applications Development, Oracle. “With Claw-powered Fusion Agentic Applications for supply chain operations, supply chain teams can reimagine the way they work by moving to governed action across critical supply chain processes. The applications reason across Oracle Fusion Applications data, evaluate options and trade-offs, coordinate the work required to meet business objectives, and carry approved actions into execution. This will help supply chain leaders drive stronger business outcomes with greater speed, consistency, and confidence.”

Agentic Applications represent a new class of outcome-based applications that provide Fusion Applications customers with a system of outcomes, where people define the objectives, authority, and accountability and the Agentic Applications coordinate the process to get to an outcome within those parameters. Fusion Claw enables Agentic Applications to take on more complex, specialist-grade work by providing a new execution runtime that supports larger scale and longer-running work, continuous replanning, deterministic execution, and governed automation within organizational policies and controls.

Running on Oracle Cloud Infrastructure, powered by industry-leading LLMs, and extending the world’s most complete suite of cloud applications, the new Fusion Agentic Applications move beyond assistance to governed execution, helping supply chain teams and planners to improve business outcomes. New Fusion Agentic Applications available within Oracle Fusion Cloud Supply Chain & Manufacturing (SCM) include:

Supply Planning Allocation: Determines how to allocate scarce materials and capacity across competing demand by evaluating production lines, work centers, finished goods, components, and business trade-offs; comparing allocation scenarios; and preparing high-value allocation plans for teams to review, refine, and approve.Shipment Load Planning: Works to reduce transportation costs and meet service level requirements by evaluating consolidation opportunities across timing, capacity, service commitments, cost, and other constraints; comparing alternatives; and taking approved action towards execution plans that have been authorized.Procurement Spend: Works to improve spend control by analyzing spend, supplier agreement, and purchasing data; detecting maverick spend and contract leakage; explaining root causes; quantifying savings opportunities; and recommending corrective actions for team review and approval.

The new Claw-powered Fusion Agentic Applications are part of a broader Fusion AI ecosystem anchored by Oracle AI Agent Studio for Fusion Applications. With the Fusion Agentic Applications Builder and AI Studio Skill no-code and pro-code capabilities in Oracle AI Agent Studio, organizations can create and manage agentic applications using reusable Oracle, partner, and external agents. In addition, built-in observability, ROI measurement, and safety controls are designed to help organizations monitor agent activity, apply appropriate safeguards, and enable agents to deliver measurable value and operate responsibly at scale.

To learn more about Oracle Fusion Applications, visit www.oracle.com/applications

About Oracle Fusion Cloud Applications
Oracle Fusion Cloud Applications are a complete suite of cloud applications that form the enterprise system of record, spanning finance, HR, supply chain, manufacturing, sales, service, and marketing. The suite includes Oracle Fusion Cloud Enterprise Resource Planning (ERP), Oracle Fusion Cloud Human Capital Management (HCM), Oracle Fusion Cloud Supply Chain & Manufacturing (SCM), and Oracle Fusion Cloud Customer Experience (CX).

Fusion Agentic Applications extend that foundation into a system of outcomes. They can coordinate and execute end-to-end work toward business objectives, and are designed to operate within the policies, controls, and authority each organization defines. With Oracle AI Agent Studio for Fusion Applications, customers and partners can create, extend, and manage these agents and agentic applications combining trusted enterprise data with the security, data governance, and performance needed to operate at scale.

About Oracle
Oracle offers integrated suites of applications plus secure, autonomous infrastructure in the Oracle Cloud. For more information about Oracle (NYSE: ORCL), please visit us at www.oracle.com.

About Oracle AI World
Oracle AI World is where customers and partners discover the latest product and technology innovations, see how AI is being applied across industries, and connect with experts and peers. Attendees will gain practical tips and insights to drive immediate impact within their organizations and explore how Oracle is helping unlock the full potential of AI. Join the event to see new capabilities in action and hear from thought leaders and industry movers. Register now at oracle.com/ai-world or follow the news and conversation at oracle.com/news and linkedin.com/company/oracle. 

Trademarks
Oracle, Java, MySQL, and NetSuite are registered trademarks of Oracle Corporation. NetSuite was the first cloud company—ushering in the new era of cloud computing.

View original content to download multimedia:https://www.prnewswire.com/news-releases/oracle-introduces-claw-powered-fusion-agentic-applications-for-supply-chain-302919020.html

SOURCE Oracle

Continue Reading

Trending