- AIM™ vector system is a novel AAV-based vector technology platform that may target CNS and other tissues with increased efficiency and tissue specificity
- Exclusive worldwide license adds ABO-202, an AAV gene therapy product, for the treatment of CLN1 patients with infantile neuronal ceroid lipofuscinosis (INCL, infantile Batten disease) to Abeona’s Batten pipeline; clinical trials anticipated 2017
Key Benefits of Public vs. Private Cord Blood Banking
The cord blood banking industry first emerged in the early 1990’s with the formation of three private cord blood banks within the United States, Cord Blood Registry, Cryo-Cell, and Viacord, all of which are AABB accredited banks.
Benefits of Cord Blood Banking | Public and Private
In this article:
- Cord Blood Banking Companies
- Key Benefits of Public Cord Blood Donation
- Key Benefits of Private Cord Blood Storage
Cord Blood Banking Companies
Over the past twenty years, cord blood banks have since become common across North America, South America, Europe, Asia, and the Middle East.
Today, a major variable within the cord blood banking industry is the divide between private and public cord blood banking. [Read more…]
UK Regulatory Authority Approves Cynata Therapeutics’ Phase I GvHD Clinical Trial
- UK regulatory authority MHRA approves Phase 1 trial with Cymerus(TM) MSCs
- World first clinical trial with allogeneic iPSC-derived product
- Major milestone for stem cell therapeutics and regenerative medicine
- Cements Cynata’s global leadership in second generation MSC therapeutics
Cynata Approved to Launch World’s 1st Clinical Trial with an Allogeneic iPSC-Derived Product
In a major world first, Australian stem cell company Cynata Therapeutics (ASX:CYP) announced it received advice from the UK Medicines and Healthcare products Regulatory Agency (MHRA) that its Phase I clinical trial application has been approved.
The clinical trial has been named “An Open-Label Phase 1 Study to Investigate the Safety and Efficacy of CYP-001 for the Treatment of Adults With Steroid-Resistant Acute Graft Versus Host Disease” (NCT02923375).
It will be the world’s first clinical trial involving a therapeutic product derived from allogeneic (unrelated to the patient) induced pluripotent stem cells (iPSCs).
Highlights of Cynata Therapeutics’ Upcoming Phase 1 Clinical Trial (Protocol Number: CYP-GvHD-P1-01)
Participants for Cynata’s upcoming Phase I clinical trial must be adults who have undergone an allogeneic haematopoietic stem cell transplant (HSCT) to treat a haematological disorder and subsequently been diagnosed with steroid-resistant Grade II-IV GvHD.
The first eight participants will be enrolled in Cohort A and receive two infusions of CYP-001 at a dose of 1 million cells per kilogram of body weight (cells/kg), up to a maximum dose of 100 million cells.
There will be one week between the two CYP-001 infusions in each patient.
The next eight participants will be enrolled into Cohort B and receive two infusions of CYP 001 at a dose of 2 million cells/kg, up to a maximum dose of 200 million cells.
The primary objective of the trial is to assess safety and tolerability, while the secondary objective is to evaluate the efficacy of two infusions of CYP-001 in adults with steroid-resistant GvHD.
Efficacy will be assessed on the basis of response to treatment (as determined by change in GvHD Grade) and overall survival at 28 and 100 days after the administration of the first dose.
Participants will also be followed up for up to two years under a separate non-interventional study protocol.
Importantly, Cynata’s Cymerus™ mesenchymal stem cell (MSC) technology is a second generation process that does not rely on multiple donors or massive expansion of the end product, and therefore, is a commercially viable solution to the manufacture of consistent, robust MSC therapeutic products.
“10 Years of iPSCs” Explores Future Growth as iPSC Field Enters 2nd Decade
To celebrate the decade that has passed since the landmark discovery of induced pluripotent stem cells, Cell Press hosted “10 Years of iPSCs,” a symposium focused on iPSC research and applications. In 2006, Shinya Yamanaka and Kazutoshi Takahashi reported the Nobel Prize winning discovery of induced pluripotent stem cells (iPSCs) in Cell.
Over the past 10 years, iPS cells have become a lab workhorse — providing an unlimited supply of once-inaccessible human tissues with specific genetic mutations for research.
iPSC technology also spurred renewed interest in direct reprogramming across lineages. Progress in understanding the biology of iPSCs and reprogramming has moved in parallel with work on clinical translation to apply the insights obtained, and the first iPSC-based clinical trials are now underway within Japan and launching within the UK.
About “10 Years of iPSCs” by Cell Press
Cell Press is excited to bring together leaders in biology, medicine, and industry to give an up-to-date view of this exciting and rapidly moving area. At this meeting, you can expect to hear about the latest advances in technology development, mechanistic understanding, and therapeutic application of reprogramming for both drug development and cell-based therapy.
The goal of the meeting is to serve as a catalyst for new ideas and future growth as the iPSC and reprogramming field enters its second decade.
Key themes will include:
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- Mechanisms of reprogramming
- Disease modeling and drug discovery
- Direct reprogramming
- Technology development
- Clinical translation
There will also be a panel on ethical considerations for clinical translation of iPSC research, on Sunday, September 25, 2016, from 17:00-18:00.
Symposium speakers Shinya Yamanaka, George Daley, Christine Mummery, Lorenz Studer, and Deepak Srivastava, and Bioethicist Hank Greely will discuss the most pressing ethics issues facing the field as it moves towards the clinic. Discussion topics will range from the ethics of patient and donor consent in iPSC banking and application to medical use of genome-edited iPSC derivatives and lessons from existing approaches in gene and cell therapy.
Speakers at “10 Years of iPSCs” Symposium
The keynote speakers for the “10 Years of iPSCs” are Shinya Yamanaka (Japan/USA) and Rudolf Jaenisch (USA).
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