InMed Submits Form 12b-25

VANCOUVER, British Columbia, Feb. 09, 2023 (GLOBE NEWSWIRE) -- InMed Pharmaceuticals Inc. (“InMed” or the “Company”) (Nasdaq: INM), a leader in the pharmaceutical research, development and manufacturing of rare cannabinoids and cannabinoid analogs, today announces it has submitted a Form 12b-25 with the U.S. Securities and Exchange Commission (the “SEC”) in connection with its Quarterly Report on Form 10-Q for the period ended December 31, 2022 (the “Form 10-Q”).

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InMed Submits Form 12b-25

Stem cell – Adult stem cells | Britannica

Some tissues in the adult body, such as the epidermis of the skin, the lining of the small intestine, and bone marrow, undergo continuous cellular turnover. They contain stem cells, which persist indefinitely, and a much larger number of transit amplifying cells, which arise from the stem cells and divide a finite number of times until they become differentiated. The stem cells exist in niches formed by other cells, which secrete substances that keep the stem cells alive and active. Some types of tissue, such as liver tissue, show minimal cell division or undergo cell division only when injured. In such tissues there is probably no special stem-cell population, and any cell can participate in tissue regeneration when required.

The epidermis of the skin contains layers of cells called keratinocytes. Only the basal layer, next to the dermis, contains cells that divide. A number of these cells are stem cells, but the majority are transit amplifying cells. The keratinocytes slowly move outward through the epidermis as they mature, and they eventually die and are sloughed off at the surface of the skin. The epithelium of the small intestine forms projections called villi, which are interspersed with small pits called crypts. The dividing cells are located in the crypts, with the stem cells lying near the base of each crypt. Cells are continuously produced in the crypts, migrate onto the villi, and are eventually shed into the lumen of the intestine. As they migrate, they differentiate into the cell types characteristic of the intestinal epithelium.

Bone marrow contains cells called hematopoietic stem cells, which generate all the cell types of the blood and the immune system. Hematopoietic stem cells are also found in small numbers in peripheral blood and in larger numbers in umbilical cord blood. In bone marrow, hematopoietic stem cells are anchored to osteoblasts of the trabecular bone and to blood vessels. They generate progeny that can become lymphocytes, granulocytes, red blood cells, and certain other cell types, depending on the balance of growth factors in their immediate environment.

Work with experimental animals has shown that transplants of hematopoietic stem cells can occasionally colonize other tissues, with the transplanted cells becoming neurons, muscle cells, or epithelia. The degree to which transplanted hematopoietic stem cells are able to colonize other tissues is exceedingly small. Despite this, the use of hematopoietic stem cell transplants is being explored for conditions such as heart disease or autoimmune disorders. It is an especially attractive option for those opposed to the use of embryonic stem cells.

Bone marrow transplants (also known as bone marrow grafts) represent a type of stem cell therapy that is in common use. They are used to allow cancer patients to survive otherwise lethal doses of radiation therapy or chemotherapy that destroy the stem cells in bone marrow. For this procedure, the patients own marrow is harvested before the cancer treatment and is then reinfused into the body after treatment. The hematopoietic stem cells of the transplant colonize the damaged marrow and eventually repopulate the blood and the immune system with functional cells. Bone marrow transplants are also often carried out between individuals (allograft). In this case the grafted marrow has some beneficial antitumour effect. Risks associated with bone marrow allografts include rejection of the graft by the patients immune system and reaction of immune cells of the graft against the patients tissues (graft-versus-host disease).

Bone marrow is a source for mesenchymal stem cells (sometimes called marrow stromal cells, or MSCs), which are precursors to non-hematopoietic stem cells that have the potential to differentiate into several different types of cells, including cells that form bone, muscle, and connective tissue. In cell cultures, bone-marrow-derived mesenchymal stem cells demonstrate pluripotency when exposed to substances that influence cell differentiation. Harnessing these pluripotent properties has become highly valuable in the generation of transplantable tissues and organs. In 2008 scientists used mesenchymal stem cells to bioengineer a section of trachea that was transplanted into a woman whose upper airway had been severely damaged by tuberculosis. The stem cells were derived from the womans bone marrow, cultured in a laboratory, and used for tissue engineering. In the engineering process, a donor trachea was stripped of its interior and exterior cell linings, leaving behind a trachea scaffold of connective tissue. The stem cells derived from the recipient were then used to recolonize the interior of the scaffold, and normal epithelial cells, also isolated from the recipient, were used to recolonize the exterior of the trachea. The use of the recipients own cells to populate the trachea scaffold prevented immune rejection and eliminated the need for immunosuppression therapy. The transplant, which was successful, was the first of its kind.

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Stem cell - Adult stem cells | Britannica

Adult Stem Cells for Regenerative Therapy – PubMed

Cell therapy has been identified as an effective method to regenerate damaged tissue. Adult stem cells, also known as somatic stem cells or resident stem cells, are a rare population of undifferentiated cells, located within a differentiated organ, in a specialized structure, called a niche, which maintains the microenvironments that regulate the growth and development of adult stem cells. The adult stem cells are self-renewing, clonogenic, and multipotent in nature, and their main role is to maintain the tissue homeostasis. They can be activated to proliferate and differentiate into the required type of cells, upon the loss of cells or injury to the tissue. Adult stem cells have been identified in many tissues including blood, intestine, skin, muscle, brain, and heart. Extensive preclinical and clinical studies have demonstrated the structural and functional regeneration capabilities of these adult stem cells, such as bone marrow-derived mononuclear cells, hematopoietic stem cells, mesenchymal stromal/stem cells, resident adult stem cells, induced pluripotent stem cells, and umbilical cord stem cells. In this review, we focus on the human therapies, utilizing adult stem cells for their regenerative capabilities in the treatment of cardiac, brain, pancreatic, and eye disorders.

Keywords: Blood disorders; Cardiospheres; Diabetes mellitus; Myoblasts; Neurogenesis; Regenerative therapy; Stem cells; Stroke.

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Adult Stem Cells for Regenerative Therapy - PubMed

About Adult Stem Cell Therapy – University of Kansas Medical Center

Adult Stem Cell Therapy 101

The initial concept of regenerative medicine dates all the way back to 330 BC, when Aristotle observed that a lizard could grow back the lost tip of its tail.

Slowly over time, humans have grown to understand regenerative medicine, and how it may change the way we treat diseases. It's been only relatively recently that adult (non-embryonic) stem cell therapy, a type of regenerative medicine, has gathered fast momentum.

Adult (non-embryonic) stem cells are unspecialized or undifferentiated cells, which means they have yet to develop into a specific cell type. Found in most adult tissues, adult stem cells have two primary properties:

Simply put, adult stem cells have the potential to grow into any of the body's more than 200 cell types.

Adult stem cells have been found in most parts of the body, including brain, bone marrow, blood vessels, skin, teeth and heart. There are typically a small number of stem cells in each tissue. Due to their small number and rate of division (growth), it is difficult to grow adult stem cells in large numbers.

Scientists at the Midwest Stem Cell Therapy Center are working to understand how to grow large amounts of adult stem cells in cell culture. These scientists are also working with more "primitive" stem cells, isolated from the umbilical cord after normal births.

Stem cell transplants, also referred to as bone marrow transplants, have been done since the late 1960s and are well-established treatments for blood cancers and bone marrow failure conditions. Umbilical cord blood also has stem cells that can be used for transplantation for these diseases.

Stem cell transplants for other diseases that use bone marrow, umbilical cord cells or other sources of stem cells are still experimental and need to viewed as such.

The practice of stem cell therapy is not new: One of the oldest forms of it is the bone marrow transplant, which has been actively practiced since the late 1960s. Since then, scientists haven't slowed down with the advancement of adult stem cell therapy.

Every day, scientists worldwide are researching new ways we can harness stem cells to develop effective new treatments for a host of diseases. In the case of a patient suffering with a blood cancer such as leukemia, a bone marrow transplant will replace their unhealthy blood cells with healthy ones.

This same concept inserting healthy cells so they may multiply and form new tissue or repair diseased tissue can be applied to other forms of stem cell therapy.

Stem cell research continues to advance as scientists learn how an organism develops from a single cell and how healthy cells replace damaged cells.

For example, the Midwest Stem Cell Therapy Center is collaborating to investigate the potential of a select group of umbilical cord stem cells in the treatment of Amyotrophic Lateral Sclerosis (ALS, or Lou Gerhig's disease).

Developing a stem cell treatment that has been shown to be both safe and efficacious is not as simple as removing stem cells from one part of the body and putting it in another.

Working with appropriate regulatory agencies, the Midwest Stem Cell therapy Center is conducting R&D activities that will permit the Center to conduct human clinical trials on a variety of diseases over the next several years.

Similar to the development of a new drug, this process when completed, will assure patients in both clinical trials and eventually patients using the approved product, that the product is safe for use in humans and the stem cells being administered are effective in treating the injury or disease they are being used for.

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About Adult Stem Cell Therapy - University of Kansas Medical Center

for Human Stem Cell Research – ahrq.gov

NICHD ADMINISTRATIVE SUPPLEMENTS FOR HUMAN EMBRYONIC STEM CELL RESEARCH RELEASE DATE: January 24, 2003 NOTICE: NOT-HD-03-005Update: July 7, 2009 This Notice is superseded by NIH-OD-09-116 NIH Guidelinesfor Human Stem Cell ResearchNational Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/)The National Institute of Child Health and Human Development (NICHD) announces the availability of administrative supplements to NICHD grantees to conduct research using human embryonic stem cell lines (ESCs) in accordance with the NIH-wide announcement and guidancethat can be found athttps://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-006.html. The human ESCs to be used must be listed on the NIH Human Embryonic Stem Cell Registry (http://escr.nih.gov/). Principal Investigators of NICHD-funded R01, R37, and P01 grants may request an administrative supplement not to exceed $75,000 direct costs (three modules) per year for two years. There must be at least two years of funding remaining on the parent grant at the time the supplement is awarded. It is intended that awards will be initiated in FY 2003 and FY 2004. Requests must be submitted not later than July 1, 2003 for FY 2003 funding or July 1, 2004 for FY 2004 funding.The work proposed must be within the scope of the parent R01, R37 or P01 grant. For example, investigators may apply concepts and technologies being used on any nonhuman adult or embryonic cells in the funded project to the study of human ESCs. The proposed research can utilize the full range of cell biological, genetic or molecular approaches. The request for an administrative supplement must include a careful description of the work proposed, an explanation of the relationship to the parent grant, and a justification for the study. The NICHD intends to commit up to $500,000 direct costs per year for this initiative in FY 2003 and FY 2004. This is a one-time announcement. However, the NICHD may re-release the announcement depending upon the needs of the NICHD scientific community and the availability of funds. Requests will be reviewed by NICHD staff. Awards will be dependent upon the receipt of qualified requests and the availability of funds. Grantees may request funds for small items of equipment, supplies, purchase of human ESCs, and personnel to work with human ESCs. Funds may also be requested to support travel and other costs needed to acquire necessary expertise in the handling of human ESCs. Investigators must independently contact the human ESC providers listed on the NIH Registry and make arrangements to obtain the cell lines, including any required material transfer agreements (MTA). Applicants must indicate which human ESC lines will be used. A letter indicating that the provider has agreed to supply the human ESC line must be furnished either with the application (see below) or just prior to the award. The investigators also should either demonstrate prior ability to work with human ESCs or outline plans for obtaining training to culture human ESCs. The human ESC providers, other laboratories with ESC experience, or laboratory training courses on ESC methods are potential means of obtaining this training. Other means for acquiring human ESC expertise may be proposed. Application ProceduresIn order to apply for an administrative supplement, it is advisable to first discuss your request with the NICHD Program Director who manages your grant or with Dr. Tasca at the address below. After this discussion, send an original letter, co-signed by the business official of the grantee institution, to your Program Director, with one copy to Dr. Tasca (below) and one copy to Ms. Hancock (below). The letter (two page limit) should include: 1) an abstract of the proposed supplemental activity and how it is related to the parent grant; 2) a description of how the requested supplement will provide the resources and expertise necessary to design and perform the experiments using human ESCs; 3) the NIH code for the selected human ESC line(s); 4) details of the budget items requested and funding period; and 5) current contact information for the Principal Investigator, including postal and email addresses. Although these descriptions should be as concise as possible, sufficient detail must be provided to allow the NICHD to determine if the request qualifies as an administrative supplement. INQUIRIESDirect inquiries regarding program and scientific issues to: Dr. Richard J. Tasca Reproductive Sciences Branch Center for Population Research National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8B01, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-6973 FAX: (301) 480-2389 Email: rt34g@nih.gov Direct questions about financial or grants management issues to: Kathy Hancock Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A17, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-5482 FAX: (301) 480-4782 Email: kh47d@nih.gov

Weekly TOC for this Announcement NIH Funding Opportunities and Notices

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for Human Stem Cell Research - ahrq.gov

What are the differences between Stem Cells and Somatic Cells?

Any cell type in a multicellular organism, except germline cells, is called a somatic cell. In contrast, stem cells are unspecialized cells with self-renewal capacity that can divide limitlessly to produce new stem cells, as well can differentiate to different cell types in the body.

Somatic cells are diploid cells, which contain two pairs of chromosomes, one received from each parent. Any cell other than germ cells (sperm and egg), gametocytes (cells that divide to form germ cells), and undifferentiated stem cells are known as somatic cells.

Unlike germ cells, somatic cells are not capable of producing offspring; instead, they form all the internal organs and tissues and contribute significantly to their functionalities.

Meiosis. Image Credit: Ody_Stocker/Shutterstock.com

Stem cells are unspecialized cells with self-renewal capacity. They can divide through mitosis limitlessly to replenish other cell types of multicellular organisms throughout their life.

After stem cell division, each newly produced cell can either remain as a stem cell or differentiate to form any other cell type with more defined functions, such as muscle cell, blood cell, or neural cell.

Under special circumstances, differentiation of stem cells can also be induced to generate tissue- or organ-specific cell types with special functions. There are mainly two types of stem cells: embryonic stem cells, which are derived from embryos, and somatic or adult stem cells, which are undifferentiated cells residing in a tissue or organ along with other differentiated cells (somatic cells).

Image Credit: Designua/Shutterstock.com

The major difference between embryonic and somatic stem cells is that embryonic stem cells have the potential to differentiate into all cell types of the body, as they are pluripotent stem cells (cells that are able to differentiate into three primary germ cell layers of the early embryo and, thus, into any cell type of the body); whereas, it is believed that somatic stem cells can differentiate only into different cell types present in the tissue of their origin.

Another type of genetically modified stem cell is induced pluripotent stem cell (iPSC). These cells are somatic stem cells that are genetically reprogramed to become like embryonic stem cells by inducing expressions of specific genes and other components necessary for maintaining embryonic stem cell properties.

Adult stem cells reside along with somatic cells in many tissues and organs, including peripheral blood, blood vessels, bone marrow, skeletal muscle, teeth, skin, gut, liver, ovary, testis, brain, and heart.

They are present in a small number and located in a specific area of each tissue called stem cell niche. Unlike somatic cells, stem cells can be in an inactive, non-dividing state for a long time until they are activated by certain internal or external signals, such as tissue injury or diseased conditions.

Adult stem cells can undergo normal differentiation pathways to give rise to specialized cells of the tissue wherein they are located. Some examples of stem cell differentiation into specialized somatic cells are as follows:

Hematopoietic stem cells differentiate into all types of blood cells, including red blood cells (RBC), B lymphocytes, T lymphocytes, neutrophils, basophiles, eosinophils, monocytes, natural killer cells, and macrophages.

Mesenchymal stem cells also known as bone marrow stromal stem cells, differentiate into different cell types, including bone cells, cartilage cells, fat cells, and stromal cells, that regulate blood production.

Neural stem cells are present in the brain and can differentiate into three major brain cell types namely neurons (nerve cells), astrocytes, and oligodendrocytes.

Epithelial stem cells are present in the epithelial lining of the gastrointestinal tract and can differentiate into different cell types, including absorptive cells, goblet cells, and enteroendocrine cells.

Skin stem cells are of two types: epidermal stem cells that are found in the basal layer of the epidermis and can differentiate into keratinocytes; and follicular stem cells that are found at the base of hair follicles and can differentiate into both follicular cells and keratinocytes.

Besides normal differentiation, adult stem cells sometimes undergo transdifferentiation, a process by which stem cells from a particular tissue differentiate into specialized cell types of another tissue. For instance, stem cells from the brain give rise to blood cells.

Despite many functional differences between stem cells and somatic cells, the ability of stem cells to differentiate into specialized cell types of the body has uncovered a potential way toward cell-based therapies, where stem cells can be used as a renewable source for replacing damaged somatic cells to treat many detrimental disorders, including heart diseases, stroke, spinal cord injury, macular degeneration, diabetes, rheumatoid arthritis, etc.

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What are the differences between Stem Cells and Somatic Cells?