Creative Medical Technology Holdings (NASDAQ:CELZ) Granted FDA Clearance To Begin Phase 1/2 Clinical Trial Of AlloStem(TM) For Addressing Chronic Lower Back Pain
- FDA clearance for phase 1/2 clinical trial is a significant milestone
- AlloStem™ treatment aims to provide a non-surgical, radiation-free procedure for chronic lower back pain
- Unique immunomodulatory formula derived from allogeneic perinatal cells sets AlloStem™ apart
- Potential to improve patient lives and reduce reliance on opioids for pain management
- Innovative treatment options could significantly improve the lives of patients grappling with chronic pain and other diseases
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The recent FDA clearance for Creative Medical Technology Holdings, Inc. to conduct a phase 1/2 clinical trial for their StemSpine® treatment, AlloStem™, represents a significant step in the development of novel regenerative therapeutics for chronic lower back pain. This development is particularly noteworthy given the high prevalence of back pain and the economic burden it imposes, with an estimated $200 billion spent annually on management.
The proprietary AlloStem™ therapy utilizes an immunomodulatory formula derived from allogeneic perinatal cells, which are known for their potential in tissue repair and influencing cytokine profiles. Cytokines are proteins that are pivotal in controlling the growth and activity of other immune system cells and blood cells. When released, they signal the immune system to do its job. Immunomodulatory treatments can alter the patient's immune response to provide therapeutic benefits.
From a medical research perspective, the advancement into clinical trials could indicate progress in non-surgical pain management options, potentially reducing reliance on opioids. This is particularly relevant in the context of the opioid crisis in the United States. If successful, the trial could lead to a new standard of care that is both effective and safer for patients.
The initiation of a phase 1/2 clinical trial by Creative Medical Technology Holdings, Inc. for a novel treatment for chronic lower back pain is likely to be of considerable interest to investors. The company's focus on a large market—20% of Americans suffer from chronic lower back pain—coupled with a treatment that could displace current opioid-based therapies, suggests a substantial potential market share and revenue stream.
Investors should note the long-term investment horizon required for biotechnology firms like Creative Medical Technology, as clinical trials and subsequent regulatory approvals can take several years. However, positive trial results can lead to significant stock price appreciation, partnerships with larger pharmaceutical companies, or even acquisition. On the flip side, any setbacks in the trial process could negatively impact the company's valuation.
It is important to monitor the company's burn rate and funding status, as clinical trials are expensive and often require additional capital. The company's ability to manage costs and secure funding without excessive dilution to existing shareholders will be crucial for its financial health and stock performance.
The biotechnology sector is highly competitive and the FDA's clearance for Creative Medical Technology Holdings, Inc. to proceed with clinical trials is a critical hurdle that has been successfully navigated. The focus on regenerative medicine and non-surgical treatments for chronic conditions such as lower back pain is a growing niche within the industry.
Regenerative medicine is an emerging field that aims to repair or replace tissue or organ function lost due to age, disease, damage, or congenital defects by using cellular therapies, tissue engineering, medical devices and artificial organs. The success of Creative Medical Technology's StemSpine® treatment, AlloStem™, could position the company as a leader in this space, especially if the treatment proves to be a viable alternative to traditional pain management strategies.
It's also worth noting that the field of regenerative medicine is subject to stringent regulatory scrutiny due to the novel nature of treatments and potential ethical considerations. Regulatory endorsements, therefore, not only validate the scientific approach but also enhance the credibility and marketability of the company's product pipeline.
PHOENIX, AZ / ACCESSWIRE / December 20, 2023 / Creative Medical Technology Holdings, Inc. (NASDAQ:CELZ), a biotechnology company has received clearance from the FDA to conduct a phase 1/2 clinical trial using their innovative StemSpine® treatment known as AlloStem™. This study aims to determine the safety, efficacy and tolerability of CELZ-201-DDT, a proprietary, ready-to-use cell line developed by the company.
The trial will focus on individuals with chronic lower back pain, providing them with an AlloStem™ injection surrounding the affected disc(s) using an ultrasound-guided, non-surgical procedure that is radiation-free. This delivery method aims to repair and remodel the surrounding tissue, improving the blood supply to the affected area and potentially alleviating the chronic pain symptoms experienced by the patient.
What sets AlloStem™ apart is its unique immunomodulatory formula derived from allogeneic perinatal cells. These cells have shown promise in tissue repair and can influence cytokine profiles, which play a crucial role in the body's immune response and tissue healing processes.
Chronic back pain affects around
"The FDA's clearance and IRB approval allowing us to pursue this clinical trial is another milestone event for Creative Medical Technology and a validation of our commitment to developing and advancing novel regenerative therapeutics that can improve patient lives," said Timothy Warbington, CEO of Creative Medical Technology. "An estimated
CELZ-201-DDT is unique because it uses a customized immunomodulatory formula made of perinatal cells derived from donors. Initial studies have shown that this formula has the potential for tissue repair and to change cytokine profiles - paving the way for further research in regenerative medicine in areas of immunotherapy, endocrinology, gynecology, urology and orthopedics.
"Chronic lower back pain is an increasing cause of disability globally," shared Courtney Bartlett, Director of Clinical Development. "This clinical trial sets the foundation to potentially help patients with a safer alternative therapy for chronic lower back pain as the procedure can be performed in the outpatient setting under direct ultrasound guidance, without any radiation exposure."
The trial seeks to enroll approximately 30 individuals, and the company is hopeful that the study will provide the necessary information to move toward a new, innovative treatment for chronic lower back pain in the future. With the necessary endorsement from the FDA and an ongoing clinical trial, Creative Medical Technology's recent developments potentially set the stage for innovative treatment options that could significantly improve the lives of patients grappling with chronic pain and other diseases.
Featured photo by Otto Norin on Unsplash.
Contact:
Apex The Equity Group Inc., Devin Sullivan
dsullivan@equityny.com
SOURCE: Creative Medical Technology Holdings, Inc.
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