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Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ) is a pioneering biotechnology holding company dedicated to advancing regenerative medicine. Headquartered in Phoenix, Arizona, the company was incorporated in 1998 and operates as a subsidiary of Creative Medical Health, Inc. It leverages innovative stem cell research to develop therapeutic applications aimed at treating male and female sexual dysfunction, infertility, miscarriages, and related health issues.
The company's flagship product, marketed under the brand name CaverStem, specifically addresses erectile dysfunction (ED). CaverStem is offered to physicians to help patients suffering from ED through stem cell-based therapies.
In recent developments, Creative Medical Technology Holdings has seen notable success in the allogeneic cell therapy market. In Q4 2022, the company unveiled the development of AlloStem™, a cell line derived from human perinatal tissue, which incorporates a Master Cell Bank and a Drug Master File. The FDA has granted approval for the CELZ-201 program, allowing it to be used in early clinical trials for type 1 diabetes. The AlloStem™ line is also being employed in the company's StemSpine® procedure to treat chronic back pain, demonstrating significant reductions in narcotic usage and pain scores among treated patients.
Allogeneic cell therapy, a cornerstone of the company's research, involves using donated cells from a healthy individual to treat patients with otherwise intractable diseases. These therapies have shown great potential in providing curative options where traditional treatments have failed.
Creative Medical Technology is heavily involved in multiple clinical trials and continues to secure necessary regulatory approvals. The company’s financial health remains robust, with significant cash reserves and no long-term debt. Furthermore, Creative Medical Technology has built a strong intellectual property portfolio with over 68 patents and pending applications.
As of the latest updates, the FDA has cleared the company to proceed with a Phase 1/2 clinical trial of StemSpine® using AlloStem™ (CELZ-201-DDT) for chronic lower back pain. The IRB approval has been received, paving the way for a placebo-controlled study that will assess the safety, efficacy, and tolerability of the treatment.
Overall, Creative Medical Technology Holdings is poised at the forefront of regenerative medicine, leveraging cutting-edge stem cell technologies to develop transformative therapies for chronic and debilitating conditions. The company’s ongoing clinical trials and strategic partnerships underline its commitment to medical innovation and improving patient outcomes globally.
Creative Medical Technology Holdings (OTC - CELZ) announced a significant publication on its clinical trial involving stem cell therapy for patients with disc degenerative disease. The study showed a mean pain score reduction from 8.9 at baseline to 1.3 at 12 months, with a noted decrease in pain medication use. The procedure was reported to have no serious adverse effects. The company is poised to commercialize this therapy, expanding its market in the multi-billion dollar industry.
Creative Medical Technology Holdings (OTC-CELZ) announced its plan to resubmit the ImmCelz® Investigational New Drug Application (IND) to the FDA due to COVID-related changes in submission requirements. The resubmission will be in electronic format to comply with the new regulations. The company has engaged an FDA consulting firm to assist with the electronic submission process. The resubmission will not alter the substance of the original application, which aims to initiate clinical trials on cellular immunotherapy for stroke treatment.
Creative Medical Technology Holdings (OTC – CELZ) announced the filing of a patent application for its ImmCelz® regenerative cell therapy, aimed at preventing organ transplant rejection. ImmCelz® works by stimulating T regulatory cells and producing Hepatocyte Growth Factor (HGF), potentially inhibiting chronic graft rejection, a leading cause of organ loss. The company has observed therapeutic effects of ImmCelz® in various conditions, including rheumatoid arthritis and kidney failure, and aims to expand its intellectual property portfolio in regenerative medicine.
On February 10, 2021, Creative Medical Technology Holdings (OTC-CELZ) revealed new data on its patented OvaStem® treatment for female infertility and ovarian failure. This treatment involves injecting stem cells to restore hormone levels and induce fertility, supported by patent #10,792,310. Recent findings show that mesenchymal stem cell injections generate T regulatory cells, enhancing ovarian function. The company aims to file for FDA clinical trials, focusing initially on premature ovarian failure, a condition affecting women under 40. The menopause market is estimated at $600 billion, highlighting significant potential.
Creative Medical Technology Holdings (OTC-CELZ) has appointed Dr. Caigan Du, an Associate Professor at the University of British Columbia, to its Scientific Advisory Board. Dr. Du is recognized for his research on kidney failure and transplant rejection, and has received funding from key organizations. He expressed enthusiasm about the potential of ImmCelz®, a regenerative therapy utilizing reprogrammed immune cells to aid kidney regeneration. This recruitment aims to enhance the company's scientific leadership in regenerative medicine.
Creative Medical Technology Holdings, Inc. (OTC – CELZ) announced promising data on ImmCelz®, revealing that its administration significantly increases hepatocyte growth factor (HGF-1) in treated animals. This study indicates that the therapeutic effects of ImmCelz® are contingent upon HGF-1. The company has previously identified therapeutic activity in various diseases, including rheumatoid arthritis and stroke. The CEO emphasized the importance of understanding biological mechanisms for attracting investments in regenerative immunotherapy, leading to new patent applications based on these findings.
Creative Medical Technology Holdings (CELZ) announced promising proof of concept studies for its ImmCelz® immunotherapy in a collagen-induced rheumatoid arthritis model. The studies highlighted that ImmCelz® effectively suppresses harmful autoimmunity without compromising normal immune functions, potentially reducing treatment-related infection risks. CEO Timothy Warbington noted the potential for rapid clinical application of these findings. ImmCelz® utilizes reprogrammed immune cells derived from adult stem cells, aiming at a significant multi-billion dollar market for autoimmune conditions.
Creative Medical Technology Holdings (OTC-CELZ) has provided an update on its corporate activities, showcasing growth in its stem cell programs. The CaverStem program is expanding, with record kit orders and new practitioners in Houston and Scottsdale. The FemCelz program is gaining traction, and marketing efforts are set to increase. A patent approval for OvaStem highlights progress in treating ovarian failure. The TregSpine and AmnioStem programs are advancing, with an IND application expected in Q4 2020. Despite challenges, the company remains optimistic about its growth.
Creative Medical Technology Holdings announced a Notice of Allowance for its patent on using T regulatory cells to enhance blood circulation for lower back pain treatment. This patent is vital as many patients suffer from poor circulation, contributing to pain. The company also holds a prior patent for stem cell therapy for lower back pain. The CEO highlighted the growing market for such therapies, citing a $1 billion deal in the sector. They are focused on expanding their intellectual property and welcome collaborations within the biotechnology community.
Creative Medical Technology Holdings (CELZ) announced new findings showing that AmnioStem® stem cells can effectively suppress stroke-related pathological molecules. These cells block harmful cytokine production and reprogram macrophages from a damaging to a reparative role, offering a potential advantage over other treatments. The company plans to publish this data and include it in its FDA IND submission. This positions the firm favorably, aiming for FDA clearance and stronger intellectual property protection.
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