chondrogen-logo

The advancement of breakthrough technologies for the past decades have enable us to develop stem cell therapy for osteoarthritis. Currently, most stem cell therapy providers in the market are using stem cell derived from bone marrow. With our own patented technology, we have successfully isolated mesenchymal stem cell from umbilical cord (Wharton’s Jelly).

This type of stem cell tissue is aseptically extracted and purified from healthy donor’s (human), and undergoes strict quality control and quality assurance regimes to produce quality stem cell product such as Chondrogen™, our own trademark stem cell product for treatment of osteoarthritis. Preliminary studies have shown that Chondrogen™ is safe and effective in treating osteoarthritis patients without surgical intervention.

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.

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.

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.

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.

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.

Asset 4

The advancement of breakthrough technologies for the past decades have enable us to develop stem cell therapy for osteoarthritis. Currently, most stem cell therapy providers in the market are using stem cell derived from bone marrow. With our own patented technology, we have successfully isolated mesenchymal stem cell from umbilical cord (Wharton’s Jelly).

This type of stem cell tissue is aseptically extracted and purified from healthy donor’s (human), and undergoes strict quality control and quality assurance regimes to produce quality stem cell product such as Chondrogen™, our own trademark stem cell product for treatment of osteoarthritis. Preliminary studies have shown that Chondrogen™ is safe and effective in treating osteoarthritis patients without surgical.

Asset 5

Chondrokin is a conditioned medium contains primary substances of cytokines and growth factors harvested from cultured umbilical cord derived mesenchymal stem cells. These group of bioactive factors act synergistically as regulators and signalling molecules to promote therapeutic effects. Chondrokin helps to stimulate the re-build of knee cartilage and has the ability to regenerate new matrix of damaged cartilage cells by reducing inflammation and pain experienced by the patient.

What is Osteoarthritis?

Osteoarthritis is one of the commonest disease in world, with a global disease burden of 83%. There are myriad of definition imposed on the disease, but the most subtle description of osteoarthritis would be as per Altman et al “a heterogenous group of conditions that lead to joint symptoms and signs which are associated with defective integrity of articular cartilage, in addition to related changes in the underlying bone and at the joint margins”. The exact pathogenesis of osteoarthritis is still poorly understood, but it is thought to be a complex interplay between mechanical, biochemical, cellular, genetic and immunologic phenomenon. Generally, osteoarthritis can be subcategorized into primary (idiopathic) and secondary osteoarthritis (post-traumatic, dysplastic, infections and inflammatory). Plain radiograph remained the main modality in diagnosing osteoarthritis. The earliest, and yet still commonly used, radiographic assessment of osteoarthritis was described by Kellgren and Lawrence in their 1957 article from the Annals of Rheumatic Diseases.

Fig. 1. Anteroposterior radiographs of the knee presented in the original Kellgren-Lawrence article.

Product-image3

Grade 1

Doubtful narrowing of the joint space with possible osteophyte formation.

Grade 2

Possible narrowing of the joint space with definite osteophyte formation.

Grade 3

Definite narrowing of joint space, moderate osteophyte formation, some sclerosis, and possible deformity of bony ends.

Grade 4

Large osteophyte formation, severe narrowing of the joint space with marked sclerosis, and definite deformity of bone ends.

After diagnosing and grading of osteoarthritis, next comes the management. According to Osteoarthritis Research Society International (OARSI) and American Academy of Orthopaedic Surgeons (AAOS), treatment of osteoarthritis can be categorized into physical measures, pharmacological therapy and surgery. While all the treatment options may benefit some patients as reflected by symptom relief, none of them can prevent the affected articular cartilage from progressive destruction.

Cartilage Injury

Early knee osteoarthritis, more often than not, demonstrates a certain degree of articular cartilage injury. The articular cartilage has minimal intrinsic capability to regenerate post injury. Healing of the articular cartilage is by formation of fibrocartilage, not the indigenous hyaline cartilage which facilitates smooth movement of the joints, in addition to flexibility. The articular lesion may propagate based on location, age, activities and knee stability. If natural progression is observed, the initial untreated articular cartilage injury will progress to secondary osteoarthritis. Hunter et al had highlighted from as early as the 18th century the importance of treating articular cartilage damage “From Hippocrates to the present age it is universally known that ulcerated cartilage is a troublesome thing and that when once destroyed it is not repaired. Since then, numerous concept of cartilage injury treatment has taken root and has continued to evolve.

Meluha-Logo-RGB-01

MELUHA THERAPEUTICS SDN BHD
Lot 1G & 2G,
Kompleks Lanai,
No.2, Persiaran Seri Perdana,
62250 Putrajaya, Malaysia.

© Meluha Therapeutics