My name is Mathias Svahn. I'm CEO of NextCell Pharma, and we develop cell therapies for autoimmune diseases and inflammatory conditions. Our drug candidate is called ProTrans. It consists of umbilical cord tissue-derived mesenchymal stromal cells. We use these cells because they have the ability to modulate the immune system, to reduce autoimmunity, but also other inflammatory conditions. We pool cells from multiple donors to generate large batches since we are treating indications with a big unmet need like type 1 diabetes. It's our primary indication. We also have clinical trials in severe pneumonia caused by viral infection and other indications in preclinical. To date, we have treated more than 90 patients in our clinical trials. We have five of them. We have shown long-term effect of a single infusion, even though these cells don't engraft. They will have a hit-and-run effect and disappear within 72 hours.
We can give repeated treatments with the same kind of therapy. It is really an off-the-shelf product. It is not even allogeneic cell therapy. It is off the shelf. We can use it to treat any patient. We have no matching between donors and recipients. It has a long shelf life in cryopreservation, more than five years. The core technology is really how we pick and choose the optimal cells. That is where our IP lies. We are now looking for regional and global licensing opportunities. The last 12 months, we have shown a broader health benefit than just preserving insulin in patients long-term. We have shown that if we give this treatment repeated, we can halt the disease progression for six years. We also completed the trials with severe pneumonia caused by viral infection. We have positive trend analysis in our pediatric trial. It is a phase II-B.
We are now also collaborating with a big company called FUJIFILM Biosciences in selling our cells on a commercial sales to biotech companies and researchers. We also have two subsidiary companies. CellaViva is the largest stem cell bank in the Nordics and increasing organically. We recently started QVons, which is a QC analytics company specifically for advanced therapy medicinal products. We have, in that company, onboarded the first client. Tomorrow is the International Diabetes Day, right? This is one of our articles that is presented in one of these. It is about Hugo. He is one of the patients in our clinical trials. He had his diagnosis at eight years. He is on insulin, but he can live almost as a normal eight-year-old. They have almost no alarms during the nights. This is what we like to achieve.
We are not treating the patients before they get their diagnosis because most do not know. We want to help the patients that have gotten their diagnosis. Our cells do not produce insulin. They are just preserving the remaining insulin. Autoimmune disease, we do not fully understand how it works, but the result of it is that the immune cells will attack the insulin-producing cells, and eventually, the patients lose the ability to produce insulin. We want to break this. Our first trial is a dose escalation trial in adults. They were diagnosed within the last two years, and they get a fixed dose, single infusion. We measure the insulin production before treatment and then one year after. This was a safety trial, but we already saw with three patients in each group a dose-dependent efficacy. 25 million cells compared to 100 and 200 million cells.
We had no severe adverse events, and the patients receiving the highest dose had the same insulin production 12 months later. We continue with this dosing and a randomized placebo-controlled double-blinded trial, same patient population. We could repeat the findings from phase I. The blue bar are the patients treated with ProTrans. They had the same level of insulin after one year, whereas the placebo patients, they vary a lot in insulin production, but on average, they lost almost half their insulin. This was also reflected in the secondary endpoint. Treated patients did not need more insulin. They were on the same dose, whereas the untreated patients needed to increase their dose by 10 units after one year. Both these are statistically significant. Single infusion, the cells are removed from the body within 72 hours, but we still can see that this is really a disease-altering therapy.
Patients treated had, on average, more insulin after five years than the placebo patients had after one year. We do not see any tendency of the curves to come together, rather the opposite. These patients have insulin pumps. They have continuous glucose measurements. They have access to our study team. They are very well in range almost all the time in both groups, even though there is a broader health benefit of having your own insulin production. Here, it is shown as BMI. The patients treated with placebo or not treated gained three and a half units in BMI over the years. This was statistically significant from two years and on. That is 15 kg on me. It is a big extra load. The ProTrans-treated patients were on the same level throughout the trial, and we are still keeping track of these patients.
It was also reflected on blood pressure. A single infusion will last for over five years. The next question is, could we give it repeatedly? The trial we did was that we asked the dose escalation patients if they were willing to be rolled over to a new trial, get a second infusion, and we could follow them for another five years. All nine accepted. That is a token of how well tolerated this therapy is. The primary endpoint was that there were no severe adverse events, no HLA antibodies. We have to be careful about overestimating the value of three patients in each group. These patients are, after six years, on the same insulin level on average as they were before treatment. Two out of three had increased levels. First dose and the second dose after one year.
All these trials have been in adults, but most frequent type 1 diagnosed, type 1 diabetes is diagnosed in the teens. We are now conducting a phase II-B where Uppsala is sponsoring this trial together with Lindsay Davies and Malmö Lund. We have treated all patients. We have shown safety in the first part. We have one-year data from the older age group, which is not the interim analysis, but just a subgroup analysis. After summer, we will have the full data set for one year. These patients are treated even earlier, within six months from diagnosis. We have what's called a honeymoon phase or remission where the patients are free from autoimmune attack for a while. Fortunately for the patients, most of the patients in this study are still in that remission.
We see positive trends when we look at the subgroup analysis, but we have to wait for the curves to separate because they are still in remission. I didn't go into the mechanism of action of our drug product, but more from a commercial point of view, this is how it looks like. It's a bag. We keep it cryopreserved for three and a half years maximum. You just thaw it bedside, connect it to an infusion bag, give it with a pump in the arm, and no washing or nothing. Twenty minutes for a child, forty minutes for an adult. It's a very accessible cell therapy. The next coming 12 months, we are continuing following with a pediatric trial, of course. We are also discussing regional markets.
There are different pathways and alternatives for specific markets to gain access, market approval, access earlier than going through the full phase III program. We will have the primary endpoint from the pediatric trial, it is called ProTrans Young, in Q3 2026. ProTrans is really a platform technology for autoimmune diseases, and we will present new indications during the year. We will also have sales of our cells through FUJIFILM Biosciences. We are also conducting some services, but I'm not able to disclose so much. It's just a promise what I'm going to show the next coming 12 months. When it comes to our subsidiary companies, we will add a new stem cell product to our biobank. We have cord tissue and cord blood. We will add placenta tissue. We also have new business-to-business opportunities. We will start distributing amniotic tissue for ophthalmology purposes, for example.
We are finding new revenue streams here. QVons, we have the first onboarded. We will seek the GMP approval to be able to provide a fully compliant QC analysis for ATMPs by, yeah, it will be submitted early next year. Thank you for that.
Despite you just saying you could not really talk about the Fujifilm thing, someone has actually asked you, but it is a bit of a broader question. More about how, if you could sort of put into words how the partnership with Fujifilm will accelerate your commercial readiness, so more from that side of things.
Fujifilm, we were supposed to have communicated more clearly what the purpose was right about now, but it is a big organization. The whole Fujifilm group is on the 500, I think.
It takes a little bit longer than expected, but it's nothing that is not ongoing as it should be, just a bit slower. It's a continuous process. Yes. The initial steps will be that we will have access to their global sales force, and they will promote our cells as high-quality MSCs for research and development purposes. We, of course, like to expand this collaboration further, but it's more related to cell culturing than to developing therapies at this point. We are moving towards their cell culturing products also for our GMP product. It's the start of the collaboration, and we will see where it takes us.
A final question then about how you assess the competitive risks both from emerging biotechs, not talks, from biotechs and already established players in the field.
Yeah, if you look at the MSC field, we really represent the second generation of MSCs that have been MSC companies, and there are two approved drug products. Our key selling point is really in the manufacturing, which I didn't bring up today. In process, we developed a panel of functional and potency assays to really identify the most potent cells. MSCs are very safe. That has never been the issue. We need to make sure that they do what they're supposed to do in the body. We have a manufacturing procedure that is patent-protected, and we have optimized a lot of things that we have had a lot to learn from, from Mesoblast and Takeda's purchase of TiGenix and others. I am very confident in our product. That's a good note to end on.
Thank you so much, Mathias. Thank you.
Thank you.