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.

See our latest film about our progress in our diabetes research.

What We Do

 

Ongoing clinical trials with ProTrans

 

NextCell Pharma is currently running two parallel trial with ProTrans for the treatment of patients with type 1-diabetes.  The first trial is ProTrans-1, 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 second clinical trial is ProTrans-Repeat which is a Phase IIa clinical trial that aims to evaluate whether repeated treatment can increase or maintain the effect of ProTrans over a longer period of time while maintaining safety. The effect is measured by comparing the patient’s ability to produce insulin before treatment, with twelve months after treatment with the repeated dose of ProTrans. This trial includes a maximum of eighteen patients, of which nine will receive active treatment and the other patients will act as the control group. All patients receiving active treatment with ProTrans have previously been treated in the ProTrans-1 study’s dose escalation phase and are now about to receive repeated treatment in the ProTrans-Repeat trial. The patients in the control group have not, and will not, receive treatment with ProTrans, but are followed to compare the natural course of diabetes with how the disease develops during treatment with ProTrans. 

 

The sponsor of the two studies is NextCell Pharma and the principal investigator is Professor Per-Ola Carlsson, working at Uppsala University and the Uppsala Academic Hospital. The studies are 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.

In order to give a more detailed update on the clinical trials and process we have created a concise schematic showing how our clinical trials have developed over time and when study completion can be expected.

Update on the clinical trial: Now we have two ongoing parallel running clinical trials!

Achieved milestones

ProTrans-1                                                                                                     ProTrans-Repeat

2019-05-17

Final patient treaed in the phase II part of the ProTrans-1 trial 

2019-05-17

All patients in the low- and medium dose cohort have now completed the trial

2019-02-22

A total of ten patients have been included, five were treated in the phase II part of ProTrans-1

2019-01-30

First two patients have been treated in the phase-II part of the clinical trial

2018-10-25

Approval by the Data and Safety Monitoring board to proceed with the second part of the trial

2018-10-14

All three patients in the high-dose-cohort treated (nine patients have been treated in total)

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 (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

2018-01-03

First patient treated

2018-01-03

First patient included

2017-12-15

First batch of ProTrans clinical grade released for usage in the clinical trial

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

 2019-06-19

First patient treated in the ProTrans-Repeat trial

 

2019-05-17

 Initiation meeting was held at Karolinska Trial Alliance, Huddinge

 2019-05-09

 Permission granted by the Medicinal Product Agency

 2018-11-15

 Clinical trial application submitted

 

 

Stem Cells Offer Unlimited Applications

 

Hematopoietic Stem Cells

 

Mesenchymal Stem Cells

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.

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.

What We Do

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.

What We Do

An “Off-The-Shelf” Product

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).

Renal Transplant

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.

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

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.

 

Contact

Karolinska Institutet Science Park
Hälsovägen 7, 141 57 Huddinge
info@nextcellpharma.com
+46 (0)8 735 55 95