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CHONDRON has been safely tested and administered to more than 350 patients over last five years

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Yash Sanghavi, MD & CEO and Satyen Sanghavi, CSO & ED, RMS Regrow elaborate on the potential of regenerative medicine and their offerings in this growing sphere, in an interaction with Usha Sharma

The DCG(I) recently approved your stem cell-based therapy to treat cartilage defects. How is it different from other existing stem cell therapies in the market?

Yash Sanghavi

Our product is fourth generation Autologous Chondrocyte Implantation (ACI), a novel medical procedure to treat articular cartilage defects of knee and ankle joints. ACI is a minimally invasive medical procedure which involves:

a) Step one includes harvest of healthy cartilage tissue from patient’s knee joint with arthroscopy (key hole). Collected healthy cartilage tissue specimen is sent under controlled temperature at 2-8°C to our Cell Processing Center (Laboratory) for culturing about three to four weeks.
b) Step two includes small opening and implantation of patient’s own cultured cartilage cells (chondrocytes) onto the cartilage defect area of the same patient.
c) When cartilage cells (chondrocytes) are implanted into a cartilage defect, chondrogenesis is initiated wherein new hyaline cartilage is formed and thus joint is preserved.

How big is the Indian cartilage regeneration market and what is its growth percentage?

Satyen Sanghavi

The Indian orthopaedic market is huge. There are about four to five lakh joint replacements, repair and reconstruction cases performed in India annually and is growing at rate of 15 per cent per annum. The orthopaedic implants segment generated the highest revenue in the global market in 2015, accounting for one-third share. The reconstructive joint replacement segment accounted for nearly two-thirds share of the global orthopaedic implants market in 2015.

Reconstructive joint replacement was the highest contributor in the orthopaedic implants market and projected to grow at a CAGR of 3.4 per cent from 2016 to 2022.

Culturally in India, a lot of activities at home or in public spaces such as temples involve bending, kneeling down or squatting on the floor and for a person suffering from osteoarthritis, performing such tasks can become near impossible.

In India, osteoarthritis is the most prevalent form of arthritis, affecting over 15 million adults every year, with over 60 million cases likely by 2025.

There is no specific treatment proven as yet that can reverse joint damage caused by osteoarthritis. Hence, the objectives of osteoarthritis management are to reduce the level of pain, reduce inflammation, slow cartilage degradation, improve function and reduce disability.

In India, where did you conduct the clinical trials and how many healthy volunteers?

CHONDRON has been safely tested and administered to more than 350 patients including clinical trial participants over last five years. The following is the city wise breakdown on the clinical trials conducted for Chondron.

Other cities include Ranchi, Nashik, Kochi, Coimbatore, Kerala, Gurgaon, Mangalore, Chandigarh, Surat, Calicut, Goa, Vadodara, Visakhapatnam, Bhilwara, Jammu, Aurangabad, Jaipur.

The distribution of Chondron cases as per indication are

  • 326 cases for knee
  • 29 cases for ankle
  • 2 cases for shoulder

What have been the results of the study?

Regrow is offering a solution which is:-

P: – Permanent – regenerated
E: – Easy (minimally invasive)
N: – Natural biological solution (Your own cells are healing you)

The results received from the trial have proved excellent safety and efficacy results. Patients have scored all end points and have reduced pain, increased mobility and new cartilage generation. There has been a success rate of 97 per cent and patients have gone back to playing professional sports.

When do you plan to commence post marketing surveillance?

We have already received market authorisation to conduct PMS. As per Drugs & Cosmetics Act, every new drug in India must undergo a four years safety evaluation to track any safety issues. However, we are commercially launching the product in May. We are in talks with major government, private, state and military hospitals to offer this product to the patients.

How much time does it take for cartilage tissue implantation? Which is the age group you are targeting for it?

The ideal age group for cartilage tissue implantation is between 15 to 65 years. With this treatment, the patient can benefit from pain relief, long term restoration of function and smooth and congruent cartilage surface.

  • The surgery does not include any foreign material
  • The shelf life is more than 30 years
  • Rehabilitation can happen in 6-12 weeks, a person can resume professional sports within a span of 6 months
  • ACI is recognised as a global natural biological solution for cell and tissue regeneration

Some of the other advantages of this treatment include:

  • Improves mobility
  • Regenerate the damage cartilage tissue
  • Regain full function
  • Helpful for professionals/ athletes
  • After three months of cell implantation, you can see new cartilage generation at defect site through X-Ray and MRI.

Will you be partnering public and private hospitals for Chondron?

Yes, we will be partnering with all types of hospitals including government, semi-government, private and military hospitals. We are looking to target cities like Mumbai, Delhi, Bengaluru, Chennai, and Hyderabad, Ahmedabad and Kolkata in phase I and then later plan to target smaller cities.

What strategies have you chalked out for commercialising the product?

We are looking for external venture capital, private equity funding and also seeking strategic partnerships with hospitals.

Are there any new products are in the pipeline and what stage are they in for completion?

One new product is in pipeline known as Uregrow which is indicated for urethral stricture patients. We have already initiated Phase II B clinical trial for this product in India. This is DBT- BIRAC part funded clinical trial.

How do you plan to raise funds for capacity expansion and marketing of cell therapy?

We will be targeting various government agencies that can provide funds for our innovations and for capacity expansions and we will also be looking at external investor/ private equities, venture capitalists.

Presently, company has the capacity to culture 1,000-1,200 patient samples annually. Do you have plans to set up new facilities or expand existing facilities?

Yes, we have planned for a new lab facility for the scale up of production/ operations.

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