The Drugs Controller General India (DCGI) granted limited approval to Stempeutics’ allogeneic stem cell product Stempeucel for the treatment of the orphan disease Buerger's Disease on Monday.
The firm – 49% of which is owned by Indian drugmaker Cipla – described the approval as “an important and historic milestone,” and is looking to globalise Stempeucel for Buerger's Disease.
The therapy consists of cultured adult mesenchymal stromal cells (MSCs) derived from multiple bone marrow donors. The firm’s patented production technology includes cell seeding densities used for the preparation of various cell bank generations, and the addition of growth factors to culture media which the firm says results in robust cell yield.
Chandru Chawla, head of Cipla New Ventures said: “Physicians now have an off-the-shelf stem cell therapy in their hand to fight Buerger's Disease. Much like the introduction of antibiotics in the late 1920's, with stem cells we have now officially taken the first step into this new paradigm of medicine.”
StemCells winds down operations
In more disheartening stem cell news, California’s StemCells Inc has announced it is winding down following the decision to terminate its Phase II Pathway Study in spinal cord injury after observing a declining trend in the effect of strength and function of its product in patients after the twelve month mark.
“We are extremely disappointed with the results of our Pathway Study, which we had hoped to be the first clinical program involving cellular transplantation to meaningfully improve motor function in patients with chronic spinal cord injury,” said CEO Ian Massey in a statement.
“However, we continue to feel immense pride over the contributions we have made to the stem cell research field, and we are confident that the progress we made will be instrumental in future studies in this area.”
The share price plummeted on the news and the firm will now evaluate opportunities to monetise its intellectual property and transfer its proprietary HuCNS-SC cells and other assets through a potential sale.
And finally, two months after the world’s first 3D printed drug was launched in the US, Israeli culture media company Accellta has teamed up with 3D printed electronics firm Nano Dimension to develop a 3D Bioprinter for stem cells.
“3D printing of living cells is a technology that is already playing a significant role in medical research, but in order to reach its full potential, for the field to evolve further, there is a need to improve printing speeds, print resolution, cell control and viability as well as cell availability and bio-ink technologies,” said Nano Dimension’s CEO Amit Dror
“By combining our high speed, high precision inkjet capabilities with Accellta's stem cell suspension technologies and induced differentiation capabilities led by a world-renown group of experienced engineers and scientists, we can enable 3D printing at high resolution and high volumes.”