Attention to Individuals Living with Buerger’s Disease – Be Part of Our Clinical Trials

Cell Biopeutics Resources is happy to announce that we have an alternative treatment that may be perfect for you. Our study aims to observe the reducing of Critical Limb Ischemia (CLI) symptoms caused by Buerger’s Disease (BD) in Malaysian population. If you meet the following criteria, you might want be eligible to participate:

  • Age 18-65 years old
  • Diagnosed with CLI due to BD (based on Shionoya criteria)
  • Presence of at least one ulcer (target ulcer) within the range of 0.5 – 1.0 cm in size
  • Ankle Brachial Pressure Index (ABPI) of 0.6
  • Willing to provide voluntary written informed consent and commit to required follow-up visits

Join us to explore new possibilities in Buerger’s Disease treatment. Your participation could contribute to advancements in medical care. Don’t miss this chance to make a meaningful impact on your own health and the lives of others. Together we can build a better future.

If you are uncertain whether you meet the requirements or are interested in participating in the study, kindly contact us via email at: researchadmin@ar.cellbiopeutics.com or call +601128668388

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Pre-Clinical Safety of Stempeucel® – Safety & Efficiency Proven

Stempeucel® Features

  • Multipotent (multilineage differentiation – adipogenesis, osteogenesis, chondrogenesis)
  • Immunosuppressive (inhibition of lymphocyte proliferation, no short-term or long-term effects on lymphocyte profile)
  • Effective engraftment to the defect site without localizing to other organs

Pre-Clinical Safety

  • No side effect observed.
  • Non-toxic, non-teratogenic and non-tumorigenic for single and multiple administration of Stempeucel® at various doses through intravenous or intramuscular routes.
  • No prenatal toxicity observed in pregnant model.
  • No tumour formation observed in severe combined immunodeficient model.
  • A death occurs one day after high dose intravenous administration of Stempeucel®. However, no treatment-related gross pathological and histopathological changes were observed. This proves that the death is unrelated to the product.

Overview of Safety in Non-Atherosclerotic Critical Limb Ischemia

  1. Single and multiple administration of Stempeucel® is safe.
  2. Stempeucel® does not elicit systemic or localized toxic effect.
  3. It is non-tumorigenic and non-teratogenic in nature.
Buerger

Marketing Phase – Buerger’s Disease Clinical Trial Findings

In normal condition, the arteries carry blood rich in oxygen and nutrients from the heart to the rest of the body, among which are the limbs such as legs and arms. When these arteries become blocked, the tissue in the limbs do not receive enough blood or oxygen, resulting in ischaemia to the limbs. Non-atherosclerotic critical limb ischaemia (CLI) is caused by Buerger’s disease, which is also called thromboangiitis obliterans. It is a segmental inflammatory disease that affects the small and medium-sized arteries and veins in the arms and legs. The blood vessels would usually swell and proper blood flow is prevented, leading to the formation of blood clots.

 

Because of the distal nature of the disease and diffuse segmental involvement, there is limited therapeutic option available as vascular bypass treatment is fairly impossible. If the condition continues untreated, it may lead to amputation and in severe cases, death. As such, the promising outcome of clinical trials with Stempeucel®, particularly in preventing limb amputation, provides the much-needed treatment alternative to avoid limb amputation caused by CLI due to Buergers disease.

Peripheral Artery Disease

Marketing Phase – Peripheral Arterial Disease Clinical Trial Findings

In healthy individuals, the arteries transport blood rich in oxygen and nutrients from the heart to the rest of the body, including the limbs such as the legs and arms. Narrowing of these arteries over time, due to the buildup of fatty deposits called plaque, leads to ischaemia in the limbs. The condition of clogged arteries in the limb is known as peripheral arterial disease.

 

Intervention available for this condition is surgical revascularization via vascular bypass. However, in certain condition where vascular bypass treatment is fairly impossible, it may lead to amputation and in severe cases, death. Hence, the encouraging results of clinical trials with Stempeucel® filled the gap of treatment needed to salvage damaged limb caused by CLI due to peripheral arterial disease.

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Osteoarthritis Clinical Trial Findings

Osteoarthritis is a degenerative disease that effects the elderly through inflammation in the joint. In young patient, the anabolic and catabolic process in the joint were regulated by a plethora of factors. However, old age may lead to the dysregulation of this balance, and osteoarthritis typically emerge as the result of cytokine storm that cause inflammation in the joint. 

 

MSCs is known to be able to regulate inflammation via secretion of various cytokines that the suppresses inflammation. Accordingly, Stempeutics had venture into the osteoarthritic indication of Stempeucel®. To date, phase I study in India, and phase II studies in India and Malaysia, demonstrated the efficacy of Stempeucel® to alleviate pain and symptoms related to osteoarthritis. As a result, Stempeucel® has received marketing approval by the Drugs Controller General of India (DCGI) for osteoarthritis indication.

DFU

Diabetic Foot Ulcer Clinical Trials Findings

Diabetes resulted in delayed wound healing due to impairment in the inflammation and angiogenesis mechanism. Diabetic ulcer most commonly happened in the foot, which is a leading cause to lower extremity amputation. MSCs is known to regulate inflammation and angiogenesis via secretion of various growth factors and cytokines that were involved in both mechanisms. DCGI has approved the phase 3 clinical trial for diabetic foot ulcer whereby 84 patients were divided equally to receive Stempeucel® and placebo. Study was done across India consisting of 17 hospitals. Stempeucel® injection in and around the wound bed, demonstrates accentuation of the healing process and reduction of the ulcer area.

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Stem Cells Growth Factors for Anti Ageing Serum

Overview

Aging is a natural physiological process starts from birth until maturity. However, over time, accumulation of a wide variety of molecular and cellular damage will leads to a gradual decrease in physical and mental capacity of oneself. One of the prominent changes that are related to aging is the skin and its protective function capability.

Reduction in skin firmness along with the onset of wrinkles are among the sign of skin aging. This condition is accelerated by exposure to environmental toxins including ultraviolet (UV) radiation exposure. As a result, therapies that could reduce, prevent or reverse aging process become an important subject for research and development in regenerative medicine. One of the products is stem cell-derived conditioned medium (CM), which is found to be an effective skin moisturizing and anti-aging agent.

About Photoaging

Photoaging is a form of skin aging caused by chronic exposure of human skin to solar UV radiation, which damages the structure and function of the skin. UV radiation, especially ultraviolet B (UVB) from sunlight, is one of the major environmental hazards that can induce skin damage. Over exposure to UV radiation also causes edema, erythema, hyper pigmentation, hyperplasia, inflammation, DNA damage and skin cancer.

Photoaging is characterised by wrinkles, laxity, roughness and irregular pigmentation. Wrinkles that appear preferentially on areas exposed to UVB are an outward sign of cutaneous aging. This condition is reversible through regenerative therapies, which utilizes anti-aging and skin moisturizing strategies.

Gap in Treatment Options

Current standard of care to prevent skin aging is by using topical formulations targeted to protect skin from UV radiation. Most of the topical formulations available are preventive in nature. They could not reverse the condition on the skin that was already affected by UV radiation.

Outcomes of Using Anti-ageing Serum Containing Stem Cell Growth Factors

There are several benefits observed when using the anti-ageing serum containing stem cell growth factors such as decrease in cyclobutane pyrimidine dimers (CPD) formation, reduced hyperkeratosis, epidermal hyperplasia and inflammatory cells in dermis, improved skin moisture level, reduced collagen degradation upon exposure to UVB radiation

Overview of Efficacy in Skin Rejuvenation

Stempeucel® has significant potential to overcome limitations of conventional treatment approaches for photoaging because it has the following properties:

  1. Ability to promote cell migration
  2. Photo protective properties
  3. Ability to reduce UV-induced skin damage
  4. Ability to promote skin regeneration
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Introduction to Mesenchymal Stem Cell Therapy

Mesenchymal stem cells (MSCs) are adult stem cells located through out the human body and can be transformed into different type of cells such as cartilage cell, bone cell and fat cells. MSCs can be isolated from various tissues such as from bone marrow, adipose, umbilical cord, umbilical cord blood and placental.  Due to its ability to transform multi-directionally, MSCs have a crucial role in tissue regeneration and in fighting inflammation. 

MSCs are easily obtainable through various source and still sustain their characteristics and properties of stem cell even after being culture for a while. MSCs are  a self-renew and a multipotent cells which means MSCs can transform to various type of specialized cell such as cardiac muscle cells, liver cells, muscle, bone, adipose and neurons.

Moreover, MSCs can play an immune regulatory role by interacting with immune cells and it also exhibit paracrine action. Immune rejection will not be easily triggered when utilizing MSCs as they have the feature of low immunogenicity which enables allograft matching. This shows that MSCs can be utilized as a potential therapeutic treatment for organ and tissue damage caused by pathological changes and ageing, as well as have a wide range of clinical application prospects such as treatment for autoimmune diseases, inflammation-related diseases and cancer.

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Mahindra to lead Ford’s India operations; new JV to focus

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Reality check: Corporate tax cut unlikely to increase investment or employment

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Sed ut perspiciatis unde omnis iste natus error sit voluptatem accusantium doloremque laudantium, totam rem aperiam, eaque ipsa quae ab illo inventore veritatis et quasi architecto beatae vitae dicta sunt explicabo. Nemo enim ipsam voluptatem quia voluptas sit aspernatur aut odit aut fugit, sed quia consequuntur magni dolores eos qui ratione voluptatem sequi nesciunt. Neque porro quisquam est, qui dolorem ipsum quia dolor sit amet, consectetur, adipisci velit, sed quia non numquam eius modi tempora incidunt ut labore et dolore magnam aliquam quaerat voluptatem. Ut enim ad minima veniam, quis nostrum exercitationem ullam corporis suscipit laboriosam, nisi ut aliquid ex ea commodi consequatur? Quis autem vel eum iure reprehenderit qui in ea voluptate velit esse quam nihil molestiae consequatur, vel illum qui dolorem eum fugiat quo voluptas nulla pariatur? At vero eos et accusamus et iusto odio occaecati cupiditate non provident, similique sunt in culpa qui officia deserunt mollitia animi, id est laborum et dolorum fuga. Et harum quidem rerum facilis est et expedita distinctio.

Sed ut perspiciatis unde omnis iste natus error sit voluptatem accusantium doloremque laudantium, totam rem aperiam, eaque ipsa quae ab illo inventore veritatis et quasi architecto beatae vitae dicta sunt explicabo. Nemo enim ipsam voluptatem quia voluptas sit aspernatur aut odit aut fugit, sed quia consequuntur magni dolores eos qui ratione voluptatem sequi nesciunt. Neque porro quisquam est, qui dolorem ipsum quia dolor sit amet, consectetur, adipisci velit, sed quia non numquam eius modi tempora incidunt ut labore et dolore magnam aliquam quaerat voluptatem. Ut enim ad minima veniam, quis nostrum exercitationem ullam corporis suscipit laboriosam, nisi ut aliquid ex ea commodi consequatur? Quis autem vel eum iure reprehenderit qui in ea voluptate velit esse quam nihil molestiae consequatur, vel illum qui dolorem eum fugiat quo voluptas nulla pariatur? At vero eos et accusamus et iusto odio dignissimos ducimus qui blanditiis praesentium voluptatum deleniti atque corrupti quos dolores et quas molestias excepturi sint occaecati cupiditate non provident, similique sunt in culpa qui officia deserunt mollitia animi, id est laborum et dolorum fuga. Et harum.