India's first allogeneic cell product Stempeucel has been approved for sale!

APRIL, Aug. 26 (Xinhua) -- Indian drug company Cipla has announced that its partner Stemeutics Research Pte Ltd has received regulatory approval from the Indian Drug Administration (DCGI) to launch Stempeucel ® in India. Product adaptation: Used to treat severe limb ischemia (CLI) caused by Buerger's Disease( BD) and Atherosclerotic External Arterial Disease (Atherosclerotic Arterial Disease, ASPAD).
it's worth noting that Stempeucel® is the first isotope cell therapy product approved for commercial use in India and the first stem cell product in the world to be approved for the treatment of CLI.
clim is an aggressive exosyctic artery disease that reduces blood flow due to severe blockages in the arteries.
this can lead to ulcers and wounds in the legs and feet and a higher risk of amputation.
estimates that about 5 million people in India are affected by the debilitating disease.
current modern vascular technology, it is estimated that only 25% of patients will receive satisfactory clinical results.
Stempeucel ® breakthrough treatment designed to enhance the body's limited ability to restore isoemia tissue blood flow.
the product is an allogeneic hybrid interstuming stem cell (MSC) isolated from the bone marrow of a healthy adult voluntary donor.
this product can directly address the root causes of the disease, by reducing inflammation, stimulating the growth of lateral blood vessels, repairing damaged muscles, thereby reducing pain, healing ulcers, and saving the limb.
the product is injected by intramuscular injections around the calf muscle area and the ulcer area.
Stempeutics has spent 12 years developing Stempeucel® a breakthrough stem cell therapy that provides an efficient production process that enables patients to access treatment products that address the root causes of the disease at an affordable cost.
manufacturing of Stempeucel®, a master cell bank produces more than 1 million doses of cell therapy, providing patients with consistent products that are unique in regenerative medicine.
-patented technology also helps Stempeucel expand ® potential for treatment in a variety of disease categories.
under the agreement signed between the two companies, Sipra has been awarded exclusive rights to sell and distribute Stempeucel ® in India, and the company will take advantage of its extensive distribution in India to make treatment available to a wide range of patients.
, Stempeutics is developing strategies for other international markets, including the United States, the European Union and Japan.
the global market for severe limb isoemia (CLI) treatments is expected to reach $5.39 billion by 2025, with a compound annual growth rate of 8.1% from 2020 to 2025.
, Senior Vice President of Medical and Regulatory Affairs at Stempeucel Preparation Process, said, "We are pleased to receive DCGI's marketing approval for this very important adaptation.
in the CLI, fat deposits block the arteries in the legs, causing a significant reduction in blood flow, pain at rest, ulcers that cannot heal and gangrene.
of amputation and death for patients with CLI.
now, Stempeucel ® provide a new, effective treatment and hope for a better quality of life for such CLI patients.
BN, Managing Director and Chief Executive Officer of Stempeutics, said: "The approval of DCGI for Stempeucel ® is an important and historic milestone for Stempeutics.
is a strong recognition of Stempeutics' continued excellence in science and clinical work and highlights our global leadership in allogeneic, hybrid MSC technologies.
believes that Stempeucel ® a game-changer that will provide an advanced treatment for millions of people with this terrible disease.
Vohra, Managing Director and Global Chief Executive Officer of Sepra, said: "Our focus on innovation is guided by our strong sense of responsibility to address unsolved patient needs and alleviate pain.
we are pleased to see that our decade-long partnership with Stepeutics has reached an important milestone.
that CLI is a serious and painful disease that affects patients around the world, and we are pleased that we have been able to launch this stem cell therapy in India at a low cost.
" original origin: Cipla and Stempeutics collaborate for launch of Stempeucel? , first 'Made in India' Cell Therapy to Treat Critical Limb Ischemia (CLI)