The Benefits of ACP-01 Stem Cell Therapy: Can it Save Limbs and thereby Lives?July 5, 2023
Stem cells, the remarkable building blocks of life, possess the unique ability to develop into various specialized cell types in the body, making them crucial for growth, tissue repair, and regeneration. There are two sources of stem cells. Those that come from the patient and those that come from a donor.
There are three primary types of stem cells:
Embryonic stem cells are derived from early-stage embryos and have the broadest differentiation potential, capable of generating any cell type in the body, but they face an ethical and political hurdle.
Adult stem cells reside in specific organs or tissues and contribute to their maintenance and repair. Induced pluripotent stem cells are artificially reprogrammed patient or donor cells that resemble embryonic stem cells. They provide a potential alternative source, but their reprogramming for patient-specific stem cells is years away from producing a product that is proven safe and effective.
Hemostemix’s adult-patient-sourced stem cells are one of the most advanced, safe, and successfully used treatments for heart disease and peripheral arterial disease.
Like all stem cells, adult stem cells have the remarkable ability to divide and differentiate into specialized cell types within the same tissue or organ. Thus, they play a crucial role in the body’s maintenance and repair processes.
The primary function of Hemostemix’ ACP-01 adult cells is to replenish circulation in tissues and organs damaged by a lack of circulation. When an injury occurs like a heart attack, or tissues are damaged from prolonged reduced circulation, ACP-01 transform into the specific cell types needed for repair.
Once injected, ACPs create new circulation as neovascularization at the site of need, and they signal to recruit other stem cells to their location to aid in its regeneration.
One remarkable characteristic of Hemostemix’s ACP-01 is the Company’s ability to produce identical copies of the patient specific cells at scale. Since the patient is the source of ACP-01, this ensures the ACP-01 cells that are available for tissue repair and regeneration are identical and patient specific.
As the patient’s DNA, they contain the embedded coding to home to the site of need, engraft into it, regenerate it, and recruit other stem cells to the task of its regeneration. These signalling characteristics and qualities are not embedded in donor stem cells or iPSCs to the same extent. It is these signaling properties and processes that have set Hemostemix’s results apart from its competitors.
Hemostemix’ clinical trials data and compassionate treatment experiences, 498 safe treatments to-date, demonstrate that ACP-01 offer patients suffering from ischemia a compassionate treatment to alleviate their condition.
The Company’s researchers are also working on NCP-01, completing an animal study to demonstrate NCP-01 can treat chronic pain associated to decreased functionality in the central nervous system. As well, Chris McNorgan, PhD, is working on an initiative to create a license agreement of NCP-01 with Neuralink or its competitors, as Dr. McNorgan’s research is directly relatable to neural electrode-based implantation.
In a stroke model, a previous animal study of NCP-01 completed at the Institute of Experimential Medicine, Czech Republic, NCP-01 demonstrated its ability to home to the site of stroke, engraft at the site of stroke, irrespective of three different methods of injection ((i) skin, (ii) muscle (iii) vein).
Like ACP-01, the Company posits that it is NCP-01’s homing properties and processes that will better facilitate the implantation and acceptance of electrodes. Both NCP-01 coated electrodes, and homing to the site of implantation will facilitate the electrode’s longevity and signaling capacities.
Hemostemix also has patents on the derivation of heart cell precursors (CCP-01) from the same source product, the patient’s blood. Like NCP-01, the Company foresees a program, including partnerships, to move CCP-01 into organ grafts, to create a replacement heart that is populated with the patient’s own ACP-01 and CCP-01, reducing the likelihood of rejection or the need for immunosuppression.
In this guide, we’ll tell you more about the benefits of stem cell therapy and how it can treat the underlying condition.
What is Stem Cell Therapy?
Stem cell therapy is a form of regenerative medicine that works to promote repair of the body. Hemostemix trademarked Your Fountain of Youth™ as it, in a phrase, helps one understand that we can use our own stem cells to maintain our health, or regenerate it when faced with angina, ischemic heart disease, critical limb ischemia, or peripheral arterial disease, for example.
What is the Best Source of Stem Cells?
There are many sources of stem cells. The first question to ask is do they come from your own body, or a donor? Stem cells that come from your own body are adult stem cells, otherwise known as autologous stem cells, verses stem cells that come from a donor, which are allogenic stem cells.
Using your own stem cells has specific advantages. For example, ACP-01 is processed in the patient’s blood serum to retain all of the patient’s natural signaling processes, which it leverages to home to the site of need, engraft at the site of need, and recruit other stem cells to the site of need to regenerate it.
What are the Benefits of Hemostemix’ Stem Cell Therapy?
The benefits that are associated with ACP-01 include enhanced blood flow, improved heart function, healing of ulcerating wounds, saving a limb from amputation, significantly reduced pain associated to wounds that heal, improved exercise capacity and improved quality of life.
- Enhanced blood flow: ACP-01 therapy improves blood circulation in patients with CLI, PAD, Ischemic and non-Ischemic Cardiomyopathy, and Angina. By injecting autologous (patient’s own) stem cells into the affected areas, the treatment intends to promote the formation of new blood vessels and improve blood flow to the tissue or organs that signal they are ischemic .
- Reduced pain and improved quality of life: CLI, for example, often causes severe pain even at rest and limits mobility, impacting the quality of life for affected individuals. ACP-01 therapy alleviates pain as it promotes wound healing, and improves functional outcomes, which enhances patients’ overall quality of life.
- Non-invasive procedure: ACP-01 is safe as it utilizes the patient’s own cells, which are extracted from a small amount of blood obtained through a blood donation-like procedure. This autologous approach reduces the risk of immune rejection, adverse reactions associated with foreign DNA, including difficult to detect diseases.
- Improved quality of life and long-term benefits: ACP-01 therapy stimulates the formation of new blood vessels, a process known as angiogenesis. 93.5% of treated limbs in a phase II clinical trial were saved from amputation. Improved blood flow to the ischemic limbs provides long-lasting benefits, as it reduced the risk of amputation and improved overall limb function. Saving a limb from amputation is saving a life, as the CLI mortality rate is greater than 60% five years following limb amputation.
Are Recovery Times Fast?
Safe and minimally invasive, a major benefit of ACP-01 is that the process to acquire it, the patient’s blood, is a safe outpatient procedure done routinely day after day. There is no hospital visit required and no recovery time required from a blood draw.
As the physician receives ACP-01 in ready to use syringes from Hemostemix, the process to treat a patient for critical limb ischemia can be done in the physician’s clinic as an outpatient procedure. Both sourcing the patient’s blood and completion of the injections of ACP-01 reduces hospitalizations, significantly reduces procedure costs, while improving the patients’ recovery times.
Considering ACP-01 Therapy
What conditions can ACP-01 treat?
If you suffer from conditions such as critical limb ischemia, or peripheral arterial disease, you may want to consider ACP-01 therapy. It is safe, less invasive than stents or bypass surgery, requires very little recovery time, and is available as an exemption approved compassionate treatment in most jurisdictions.
Lastly, ACP-01 may be used consecutively as treatments to promote healing, reduce chronic pain, rebuild functionality, and improve quality of life.
Want to learn more about ACP-01 therapy? Get in touch today to learn more about how we can help meet your needs.
For further information, please contact: Thomas Smeenk, President, CEO & Co-Founder
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Forward-Looking Information: This news release contains “forward-looking information” within the meaning of applicable Canadian securities legislation. All statements, other than statements of historical fact, included herein are forward-looking information. In particular, this news release contains forward-looking information in relation to: ACP-01, NCP-01, CCP-01, the presentation of the Company’s Phase II CLI trial results and its lead product ACP-01, and may make reference to the Phase II Clinical Trial of ischemic cardiomyopathy and related results, the retrospective study of ischemic and dilated cardiomyopathy, and the commercialization of ACP-01 via the sale of compassionate treatments approved by regulators. There can be no assurance that such forward-looking information will prove to be accurate. Actual results and future events could differ materially from those anticipated in such forward-looking information. This forward-looking information reflects Hemostemix’s current beliefs and is based on information currently available to Hemostemix and on assumptions Hemostemix believes are reasonable. These assumptions include, but are not limited to: the underlying value of Hemostemix and its Common Shares; the successful resolution of the litigation that Hemostemix is pursuing or defending (the “Litigation”); the results of ACP-01 research, trials, studies and analyses, including the analysis being equivalent to or better than previous research, trials or studies; the receipt of all required regulatory approvals for research, trials or studies; the level of activity, market acceptance and market trends in the healthcare sector; the economy generally; consumer interest in Hemostemix’s services and products; competition and Hemostemix’s competitive advantages; and Hemostemix obtaining satisfactory financing to fund Hemostemix’s operations including any research, trials or studies, and any Litigation. Forward-looking information is Subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of Hemostemix to be materially different from those expressed or implied by such forward-looking information. Such risks and other factors may include, but are not limited to: the ability of Hemostemix to complete clinical trials, complete a satisfactory analyses and file the results of such analyses to gain regulatory approval of a phase II or phase III clinical trial of ACP-01; potential litigation Hemostemis mayface; general business, economic, competitive, political and social uncertainties; general capital market conditions and market prices for securities; delay or failure to receive board or regulatory approvals; the actual results of future operations including the actual results of future research, trials or studies; competition; changes in legislation affecting Hemostemix; the timing and availability of external financing on acceptable terms; long-term capital requirements and future developments in Hemostemix’s markets and the markets in which it expects to compete; lack of qualified, skilled labour or loss of key individuals; and risks related to the COVID-19 pandemic including various recommendations, orders and measures of governmental authorities to try to limit the pandemic, including travel restrictions, border closures, non-essential business closures service disruptions, quarantines, self-isolations, shelters-in-place and social distancing, disruptions to markets, disruptions to economic activity and financings, disruptions to supply chains and sales channels, and a deterioration of general economic conditions including a possible national or global recession or depression;the potential impact that the COVID-19 pandemic may have on Hemostemix which may include a decreased demand for the services that Hemostemix offers; and a deterioration of financial markets that could limit Hemostemix’s ability to obtain external financing. A description of additional risk factors that may cause actual results to differ materially from forward-looking information can be found in Hemostemix’s disclosure documents on the SEDAR website at www.sedar.com. Although Hemostemix has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. Readers are cautioned that the foregoing list of factors is not exhaustive. Readers are further cautioned not to place undue reliance on forward-looking information as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Forward-looking information contained in this news release is expressly qualified by this cautionary statement. The forward-looking information contained in this news release represents the expectations of Hemostemix as of the date of this news release and, accordingly, it is Subject to change after such date. However, Hemostemix expressly disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as expressly required by applicable securities law.
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