The Stem Cell Revolution
Like the IT-revolution has changed our way to handle data and communication, stem cells will revolutionize almost any aspect of medicine including treatments for cancer, inflammatory and autoimmune disorders as well as regeneration of new tissues.
Ongoing clinical trial with ProTrans
NextCell Pharma is conducting a clinical trial with ProTrans for treatment of patients with type 1-diabetes being 18-40 years who received their diagnosis no later than 2 years ago and still have some insulin production. This is a two-part phase I/II trial design assessing the safety and efficacy of the study drug. In the first part, a dose-escalation with three patients in 3 dose cohorts is used to evaluate the safety. The second part of the trial is started after all patients in the first part have been to the 1-month follow-up visit. The second part includes 15 patients that are randomized to active treatment or placebo (2:1 ratio), both patients and investigators are blinded.
The sponsor of the study is NextCell and the principal investigator is Professor Per-Ola Carlsson, working at Uppsala University and the Uppsala Academic Hospital. The study is conducted at the KTA Phase I unit located at Karolinska University Hospital in Huddinge. Professor Ulf Smith MD, PhD, Professor Anders Fasth, MD, PhD, and Professor Åke Lernmark PhD, together form the Data Safety Monitoring Board with Ulf Smith as its chairman.
2018-06-29 Approval by the Data and Safety Monitoring board to proceed with the high-dose cohort
2018-05-18 All three patients in the medium-dose-cohort treated (now six patients have been treated in total)
2018-03-27 Approval by the Data and Safety Monitoring board to proceed with the medium-dose cohort
2018-02-22 All three patients in the low-dose-cohort treated
2018-01-23 First patient treated
2018-01-03 First patient included
2017-11-28 Initiation meeting at Karolinska Trial Alliance, Huddinge
2017-11-20 Karolinska Center for Cell Therapy approves that the trial will be conducted at Karolinska
2017-10-17 Permission granted by the Medicinal Product Agency
2017-09-04 Permission granted by the Ethics Committee
2017-07-24 Clinical trial application submitted
Welcome to NextCell Pharma
The human body is extremely complex and we need complex tools to defeat today’s incurable diseases. NextCell Pharma utilizes stem cells unique potential to restore normal body functions. The quality and potency of the stem cells is absolutely fundamental – this is our area of expertise
I welcome you to join NextCell Pharma in our mission to bring the next generation of stem cell therapy to patients.
/Dr. Mathias Svahn, CEO and founder
ProTrans™ - For Autoimmune & Inflammatory Diseases and Transplants
We are developing ProTrans™ for therapeutic immunomodulation of autoimmune and inflammatory diseases including for transplantation applications. Mesenchymal stem cells have proven to have immunomodulatory effects. ProTrans is an “off-the-shelf” product based on Wharton’s Jelly derived Mesenchymal Stem Cells (WJMSC). ProTrans is an Advanced Therapy Investigational Medicinal Product (ATIMP).
Type 1 Diabetes
Type 1 diabetes is an autoimmune condition in which the immune system is attacking the insulin producing cells in the pancreas. The causes of this autoimmune reaction is not known and is not linked to modifiable lifestyle factors. There is no cure and it cannot be prevented. Only 5% of people with diabetes have this form of the disease which is usually diagnosed in children and young adults. Between 20-40 million are living with type 1 diabetes worldwide.
ProTrans will be given to patients directly after diagnosis. It is the immunomodulating effect of the stem cells in ProTrans is given in an attempt to protect the insulin producing cells and to modulate the immune system. The effect might be transient, resulting in an longer honeymoon phase or reduced need of insulin, but the goal is to reprogram the immune system to accept the body's own insulin producing cells.
Kidney transplantation has become standard therapy for eligible patients with end stage renal disease. The number of transplants has increased rapidly over the last two decades. However, the demand for organs has increased even more. Deceased donor kidneys are the origin of the majority of all transplants, 50 000 annually. The criteria for an acceptable kidney has been modified to include so called marginal kidneys and donors. Transplants with marginal kidneys have a higher risk of rejection.
The rationale is to give ProTrans to the patient at the time of transplantation in order to protect the kidney, empowering the engraftment. High risk patients would receive ProTrans in addition to conventional immunosuppression with the purpose to foster the engraftment of the marginal kidney.
Watch Mathias Svahn at seminars and interviews
Stem Cells and Immunology in Synergy
NextCell Pharma is an innovative Biotech growing out of the need for Advanced Therapy Medicinal Products for Autoimmune Disease and Transplantation. Cellaviva, the first Swedish family saving stem cell bank, with its expertise in umbilical cord stem cells and Diamyd Medical with its interests and investments within autoimmune diseases made a natural partnership for creating NextCell Pharma. A plan for testing NextCell Pharma’s first product ProTrans in the clinic is in place.
Two Business Areas based on the same technology
NextCell Pharma develops novel treatments with stem cells from the umbilical cord. In umbilical cord and umbilical cord tissue there are young and viable stem cells that can be collected without any intervention.
- NextCell Pharma develops the drug candidate ProTrans ™, a stem cell product based on mesenchymal stem cells from umbilical cord tissue with regenerative and immunosuppressive activity.
- Cellaviva ™ is the brand name of our service for stem cell banking. We offer prospective parents a service for saving their child's stem cells for the family and the child's future medical need.
Cellaviva will always be the first Swedish family cell bank for stem cells and is the only biobank with approval from Swedish authorities. Cellaviva and NextCell Pharma have a high scientific profile with a strong network with academic researchers.
Family stem cell banking and cord blood banking is a proven business model. Expectant parents all over the world have been offered to store stem cells from their newborn children for more than two decades. Today 200 companies have stored stem cells from more than 4 million children, globally.
Read more at www.cellaviva.se
The company is located in Karolinska Institutet Science Park, adjacent to the Karolinska University Hospital. in Huddinge. The region includes a cluster for stem cell research and is a perfect location for advancing stem cell technologies.
NextCell Pharma is a tissue establishment and primary biobank, classified as healthcare provider. Its activities are inspected by the government agency, The Health and Social Care Inspectorate (IVO).