Mesenchymal Stem Cells (MSCs)

Mesenchymal stem cells (MSCs) are adult stem cells which can be isolated from human and animal sources. Human MSCs (hMSCs) are the non-haematopoietic, multipotent stem cells with the capacity to differentiate into mesodermal lineage such as osteocytes, adipocytes and chondrocytes as well ectodermal (neurocytes) and endodermal lineages (hepatocytes). MSCs express cell surface markers like cluster of differentiation (CD)29, CD44, CD73, CD90, CD105 and lack the expression of CD14, CD34, CD45 and HLA (human leucocyte antigen)-DR. hMSCs for the first time were reported in the bone marrow and till now they have been isolated from various tissues, including adipose tissue, amniotic fluid, endometrium, dental tissues, umbilical cord and Wharton’s jelly which harbours potential MSCs. hMSCs have been cultured long-term in specific media without any severe abnormalities.

Furthermore, MSCs have immunomodulatory features, secrete cytokines and immune-receptors which regulate the microenvironment in the host tissue. Multilineage potential, immunomodulation and secretion of anti-inflammatory molecules makes MSCs an effective tool in the treatment of chronic diseases. Recent research findings in the area of hMSCs sources, expression of cell surface markers, long-term in vitro culturing, in vitro differentiation potential, immunomodulatory features, its homing capacity, banking and cryopreservation, its application in the treatment of chronic diseases and its use in clinical trials deems MSCs to be potential therapeutic treatment for osteoarthritis and cartilage injury.

Mesenchymal Stem Cells (MSCs) under microscope

Mesenchymal Stem Cells (MSCs)

Mesenchymal stem cells (MSCs) are adult stem cells which can be isolated from human and animal sources. Human MSCs (hMSCs) are the non-haematopoietic, multipotent stem cells with the capacity to differentiate into mesodermal lineage such as osteocytes, adipocytes and chondrocytes as well ectodermal (neurocytes) and endodermal lineages (hepatocytes). MSCs express cell surface markers like cluster of differentiation (CD)29, CD44, CD73, CD90, CD105 and lack the expression of CD14, CD34, CD45 and HLA (human leucocyte antigen)-DR. hMSCs for the first time were reported in the bone marrow and till now they have been isolated from various tissues, including adipose tissue, amniotic fluid, endometrium, dental tissues, umbilical cord and Wharton’s jelly which harbours potential MSCs. hMSCs have been cultured long-term in specific media without any severe abnormalities.

Furthermore, MSCs have immunomodulatory features, secrete cytokines and immune-receptors which regulate the microenvironment in the host tissue. Multilineage potential, immunomodulation and secretion of anti-inflammatory molecules makes MSCs an effective tool in the treatment of chronic diseases. In the present review, we have highlighted recent research findings in the area of hMSCs sources, expression of cell surface markers, long-term in vitro culturing, in vitro differentiation potential, immunomodulatory features, its homing capacity, banking and cryopreservation, its application in the treatment of chronic diseases and its use in clinical trials.

Mesenchymal Stem Cells (MSCs) under microscope

Chondrogen™ Platform

Key Stages in manufacturing, testing and distribution process

Development Pathway

The main events for the proposed development of a Chondrogen™ and Chondrokin™ products can be summarized into the four critical areas as described. The Company will seek, wherever possible, to secure further intellectual property protection over any developments made in the course of conducting the development plan.

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Regulatory Strategy

The Company has engaged Clinical Research Officer (CRO) experts to assist in defining a regulatory strategy and negotiating the complicated regulatory path for allogeneic cell-based therapeutic products.

Meluha Therapeutics has had successful and productive interactions with regulators in key jurisdictions, and will continue to do so as the development programs progress.

Regulatory Strategy

The Company has engaged Clinical Research Officer (CRO) experts to assist in defining a regulatory strategy and negotiating the complicated regulatory path for allogeneic cell-based therapeutic products.

Meluha Life Sciences has had successful and productive interactions with regulators in key jurisdictions, and will continue to do so as the development programs progress.

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Product Manufacture, Manufacturing Process and Controls

The Company has engaged Clinical Research Officer (CRO) experts to assist in defining a regulatory strategy and negotiating the complicated regulatory path for allogeneic cell-based therapeutic products.

Meluha Therapeutics has had successful and productive interactions with regulators in key jurisdictions, and will continue to do so as the development programs progress.

Product Manufacture, Manufacturing Process and Controls

The Company has engaged Clinical Research Officer (CRO) experts to assist in defining a regulatory strategy and negotiating the complicated regulatory path for allogeneic cell-based therapeutic products.

Meluha Life Sciences has had successful and productive interactions with regulators in key jurisdictions, and will continue to do so as the development programs progress.

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Pre-clinical Testing

Before use in human subjects, a potential Chondrogen™ and Chondrokin™ products must be tested to the satisfaction of the oversight authorities. The nature of the required tests vary, depending upon the choice of indication, availability of suitable test methods and the relevant regulations. Ultimately the goal of the pre-clinical program is to demonstrate the sterility, purity, potency, stability, safety and indicative efficacy of Chondrogen™ MSCs.

Meluha Therapeutics has generated positive data in a number of studies of Chondrogen™ MSCs in animal models of disease. During these studies showed that the MSCs had a profound effect, and no safety concerns were identified.

Pre-clinical Testing

Before use in human subjects, a potential Chondrogen™ and Chondrokin™ products must be tested to the satisfaction of the oversight authorities. The nature of the required tests vary, depending upon the choice of indication, availability of suitable test methods and the relevant regulations. Ultimately the goal of the pre-clinical program is to demonstrate the sterility, purity, potency, stability, safety and indicative efficacy of Chondrogen™ MSCs.

Meluha Life Sciences has generated positive data in a number of studies of Chondrogen™ MSCs in animal models of disease. During these studies showed that the MSCs had a profound effect, and no safety concerns were identified.

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Clinical Safety and Efficacy

It is necessary to demonstrate both safety and efficacy of Meluha Therapeutics potential products before approval for commercial sale may be sought. This will involve the conduct of a series of clinical trials.

Completed for Chondrogen. Trial result shows chondrogen is safe and improve knee function and reduce knee pain.

Clinical Safety and Efficacy

It is necessary to demonstrate both safety and efficacy of Meluha Life Sciences potential products before approval for commercial sale may be sought. This will involve the conduct of a series of clinical trials.

The first human trial for osteoarthritis will be conducted with HUKM.

Our clinical trials

Meluha Therapeutics is conducting clinical studies of investigational cellular therapies in osteoarthritis (OA) disease.

Intellectual Property

One of our major goals is to continue to protect and expand our patent rights and trade secrets. We believe this enables us to deliver commercial advantages and long-term protection for our product candidates based on our proprietary technologies. Additionally this supports our corporate strategy to target large, mature and emerging cell based markets for our exploratory therapeutic product candidates.

We have a patent portfolio of issued and pending claims covering compositions of matter and uses for our Mesenchymal Stem Cell based technologies and other proprietary regenerative product candidates and technologies, as well as for elements of our manufacturing processes.

More specifically, our patent includes issued patent and patent applications in major markets, including the United States and Malaysia.

These cell manufacturing patents cover isolation, expansion, purification, scale up, culture conditions, testing method, cryopreservation, release testing and functional assays.

Ongoing R & D project

Exosomes

Exosomes are small extracellular vesicles (sEVs) capsulated by lipid bilayer with size ranges from 30 nm to 120 nm. They act as a container ship that buds off from cells and unloads cargo such as DNA, RNA proteins and lipids to the neighbouring cells. By doing this, exosomes can transiently affect the recipient cells by regulating their gene expression. Due to this, they have great potential in treating diseases in a cell free manner. Recent studies have shown exosomes have the potential in treating osteoarthritis and cartilage injury. Preliminary R&D works are ongoing to isolate the exosomes from the conditioned media harvested from the cultured umbilical cord derived mesenchymal stem cells. The isolated

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