Author: Cell2Cure

  • Endeavour Cells investment in Cell2Cure

    Endeavour Cells investment in Cell2Cure

    Cell2Cure has January 2024 received a significant equity investment from Endeavour Cell ApS, to further develop our collaboration.

    Endeavour Cells will own 51% of the company. In addition to the invested capital the collaboration with Endeavor Cells includes milestone payments and potential continued financing of Cell2Cure’s activities within a 5-year time frame.

    This collaboration will further consolidate Cell2Cure and strengthen the technological, clinical and commercial development of our very promising stem cell treatment technology.

    The overall goal for Cell2Cure is to establish stem cells as a new treatment option for several disease indications for the benefit of the patients and the society.

    Press release (in danish)

  • Cell2Cure is partner in an EU-funded project, RESTORE VISION, within rare eye diseases

    Cell2Cure is partner in an EU-funded project, RESTORE VISION, within rare eye diseases

    In Europe, approximately 30 million people suffer from blindness and visual impairment. Rare Eye Diseases are a major cause that can result in blindness in children and young adults and affect adults and the ageing population. Current management is expensive, has low efficacy, and significant side effects.

    The consortium – RESTORE VISION – aims to address this clinical need by formulating novel treatments and repurposed drugs that have been validated in different disease indications (Home – Restore vision).

    The project will target seven rare eye diseases: aniridia-associated keratopathy; neurotrophic keratopathy; limbal stem cell deficiency; ocular cicatricial pemphigoid; EEC syndrome; ocular graft versus host disease; and corneal neovascularisation.

    Cell2Cure participate in the consortium with the patented cell product: allogeneic adipose tissue-derived mesenchymal stromal/stem cells (ASCs) and our expertise within conduction of clinical trials.

    The ASC products will be tested in a clinical trial as an immunosuppressive treatment in patients with ocular graft versus host disease.

  • Cell2Cure has treated the first patients with autism spectrum disorders and signs of leaky gut syndrome in a Phase I trial

    Cell2Cure has treated the first patients with autism spectrum disorders and signs of leaky gut syndrome in a Phase I trial

    The first two children with autism spectrum disorder (ASD) and signs of leaky gut syndrome has been treated with allogeneic adipose tissue-derived mesenchymal stromal/stem cells (ASCs) at Aalborg University Hospital without any complication.

    The trial is a collaboration between Cell2Cure and Professor Marlene Briciet Lauritsen, Department of Child and Adolescent Psychiatry, Aalborg University, Aalborg University Hospital, and Endeavour Cells ApS, who holds the C2C_ASC sublicense from Cell2Cure for this indication.

    The trial hypothesis is that the connection between gastrointestinal symptoms/leaky gut syndrome increases local gastrointestinal and systemic elevated immunological and inflammatory activity, bacterial toxins in the blood and symptoms of ASD in children with symptoms of leaky gut syndrome can be reduced or normalized by modulating the immunological activity and inflammation by treatment with ASCs.

    This phase I clinical trial is investing the safety and efficacy of treatment with Cell2Cure’s ASC products. In the trial a total of 10 children with autism and signs of leaky gut syndrome will be enrolled. The children will be treated with intravenous infusion of 1 million ASCs per Kg body weight or 2 million ASCs per Kg body weight.

    Endeavour Cells is financial sponsor of the trial, and Cell2Cure is the clinical sponsor.

    This treatment concept has the potential to become a pioneering treatment of children with autism spectrum disorders and signs of leaky gut syndrome.

  • The Cell2Cure core technology has been granted patent rights in Canada

    The Cell2Cure core technology has been granted patent rights in Canada

    As of the 18th of September 2023, the patent secures Cell2Cure’s technological concept for industrial production, upscaling, and distribution of allogeneic adipose tissue-derived mesenchymal stromal/stem cell product (ASCs) products has been granted in Canada (Patent number: 3000912).

    The patent “STEM CELL THERAPY BASED ON ADIPOSE-DERIVED STEM CELLS” has previously been granted in Europe (19 European PCT countries) year 2020: Publication number EP3365432B1, and in Australia 2022: Patent number: 2016342387. The priority date is October 2016.

    Applications are still pending in China, Hong Kong, Japan, The Republic of Korea and in USA. We look forward to further strengthening of our intellectual property position for our technology.

  • Cell2Cure featured by Tech Journal »Ingeniøren«

    Cell2Cure featured by Tech Journal »Ingeniøren«

    Cell2Cure has developed a stem cell product that does not require a tissue match between donor and patient and can simply be stored in the freezer for use in various clinical purposes.

    Cell2Cure was in continuation of the pres release visited – and researched – by »Ingeniøren«, the Danish journal for technology and natural sciences.

    Read the article here (in danish)

  • Enrolment finalized in the lung transplantation phase I-II clinical trial

    Enrolment finalized in the lung transplantation phase I-II clinical trial

    Patient with severe terminal lung disease may ultimately be treated with a donor lung transplantation.
    However, transplantation of a lung from another person elicits a strong immunologic reaction by the recipient towards the transplanted donor lung.

    In the worst case, the donor lung is rejected by the patient, and the patient may die.

    To avoid or reduce an immediate immunologic reaction towards the donor lung the first days after transplantation, patients have, in a randomized doble-blinded clinical trial, been treated with Cell2Cures allogeneic adipose tissue-derived mesenchymal stromal/stem cell (ASC) products dosed at either 100 million ASCs, 200 million ASCs – or placebo, within two hours after transplantation. The aim of the trial is to obtain a significant beneficial clinical effect linked to ASCs ability to modulate the patients immunological and inflammatory response.

    The last of the 30 patients was enrolled and treated 13th April 2023. It is expected that the read-out from the entire clinical trial will be ready within the next 6 months.

  • Cell2Cure has treated the first patient with diabetic foot ulcer in the STEMFOOT (Phase I study)

    Cell2Cure has treated the first patient with diabetic foot ulcer in the STEMFOOT (Phase I study)

    The first patient with diabetic foot ulcer was treated with Cell2Cure’s allogeneic adipose tissue-derived mesenchymal stromal/stem cell product (ASCs) January 24, 2023, at Bispebjerg University Hospital, Copenhagen, Denmark. The STEMFOOT study is carried out in collaboration with Professor Ole Lander Svendsen and Wound Healing Center, Bispebjerg University Hospital.

    The study team was very encouraged by the demonstrated very easy and smooth preparation of the ASC product, which without any problems was delivered in 5 subcutaneous injections in healthy tissue around the ulcer. The outcome of the treatment will be evaluated in the following 12 weeks period.

    Diabetic foot ulcers is a very huge problem for the patients and the health care system. One of the most severe complications to diabetes is foot ulcers, which affects up to 26 million annually. A feared diabetic ulcer complication is the need for lower limb amputation and globally a diabetic person is amputated every 30 sec. There is currently no effective cure for this indication.

    This phase I clinical study STEMFOOT will investigate the safety and efficacy of treatment with C2C_ASCs in addition to conventional treatments for healing and complications of foot ulcers in diabetes patients. A total of 30 patients will be randomized 1:1 to either ASC treatment or to a control group.

    This treatment concept has the potential to become a pioneering treatment for diabetic foot ulcers.

  • The Danish Medicines Agency has approved the phase I clinical trial with allogeneic adipose tissue-derived mesenchymal stromal/stem cell (ASC) treatment of children with autism and leaky gut syndrome

    The Danish Medicines Agency has approved the phase I clinical trial with allogeneic adipose tissue-derived mesenchymal stromal/stem cell (ASC) treatment of children with autism and leaky gut syndrome

    The Danish Medicines Agency has November 23rd, 2022, approved the phase I dose-titrating clinical trial where children with autism and signs of leaky gut syndrome are treated with ASCs. The children will be treated with intravenous infusion of 1 million ASCs per Kg body weight or 2 million ASCs per Kg body weight.

    The project is a collaboration between Cell2Cure and Aalborg University, Aalborg University Hospital, and Endeavour Cells ApS, who holds the sublicense from Cell2Cure for this indication.

    The participants will be enrolled and treated at Aalborg University Hospital. Endeavour Cells will financially sponsor the trial, but Cell2Cure will have the role as clinical sponsor.

    It is expected that the trial will be ready to enroll the first participant in early 2023.

  • Ethical approval for the allogeneic adipose tissue-derived mesenchymal stromal/stem cell (ASC) phase I clinical trial in children with autism and leaky gut syndrome

    Ethical approval for the allogeneic adipose tissue-derived mesenchymal stromal/stem cell (ASC) phase I clinical trial in children with autism and leaky gut syndrome

    The Danish Medical Research Ethics Committees has November 2nd, 2022, approved a phase I dose-titrating clinical trial with allogeneic adipose tissue-derived mesenchymal stromal/stem cell (ASC) treatment of children with autism and leaky gut syndrome.

    The project is a collaboration between Cell2Cure, Aalborg University, Aalborg University Hospital, Hvidovre Hospital, and Endeavour Cells ApS, who holds the sublicense from Cell2Cure for this indication.

    The participants will be enrolled and treated at Aalborg University Hospital.

    Endeavour Cells will financially sponsor the trial, but Cell2Cure will have the role as clinical sponsor.

    It is expected that the trial will be ready to enroll the first participant in early 2023.

  • The Danish Medicines Agency has approved a Phase I trial treating diabetic foot ulcer with allogeneic adipose tissue-derived mesenchymal stromal/stem cells (ASCs)

    The Danish Medicines Agency has approved a Phase I trial treating diabetic foot ulcer with allogeneic adipose tissue-derived mesenchymal stromal/stem cells (ASCs)

    Cell2Cure will be investigating treatment of patients with diabetic foot ulcers with ASCs.

    One of the most severe complications to diabetes is foot ulcers, which affects up to 26 million annually. Lower limb amputation is a feared complication associated with foot ulcers, and globally a person is amputated every 30 sec due to diabetes. There is currently no effective cure for this indication.

    The clinical trial will be carried out in collaboration with Professor Ole Lander Svendsen and his team at Bispebjerg University Hospital, Copenhagen, Denmark. The trial was approved by the Danish Medical Research Ethics Committees on May the 30th, 2022, and by the Danish Medicines Agency on June the 28th 2022. The clinical trial will investigate safety and efficacy of treatment with ASCs in addition to conventional treatments for healing and complications of foot ulcers in diabetes patients. A total of 30 patients will be randomized 1:1 to either ASC treatment or to a control group. The ASC group will be treated with subcutaneous injections of the cell product around the ulcus and patients will be followed for 12 weeks. The first patient is expected to be treated in the autumn of 2022 and results are expected by the end of 2023.

    says Professor Jens Kastrup, CEO and Clinical Director.