Author: Cell2Cure

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

    The Cell2Cure core technology has been granted patent rights in Australia

    As of the 24th of March 2022, the patent secures Cell2Cure’s technological concept for industrial production, upscaling, and distribution of allogeneic adipose-derived mesenchymal stromal cell (ASC) products in Australia (Patent number: 2016342387).

    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. Priority: October 2016.

    Applications are still pending in Canada, China, Hong Kong, Japan, The Republic of Korea and in USA.

    We look forward to further strengthening of our intellectual property.

  • Patient enrollment finalized in the Phase II trial testing allogeneic adipose tissue-derived mesenchymal stromal/stem cells (ASCs) in Sjögren’s syndrome

    Patient enrollment finalized in the Phase II trial testing allogeneic adipose tissue-derived mesenchymal stromal/stem cells (ASCs) in Sjögren’s syndrome

    Aqueous Deficient Dry Eye Disease, Sjögren’s syndrome is a serious autoimmune disease that can cause serious eye and vision problems due to reduced tear production.

    The patient enrollment is now finalized in the randomized double-blind placebo-controlled phase II trial testing the safety and efficacy of direct injection of ASCs into the lacrimal gland in 40 patients with Sjögren’s syndrome.

    The follow-up is currently ongoing, and the final results are expected early 2023.

  • Publication of phase I results of allogeneic adipose tissue-derived mesenchymal stromal/stem cell (ASC) treatment of patients with radiation-induced Xerostomia

    Publication of phase I results of allogeneic adipose tissue-derived mesenchymal stromal/stem cell (ASC) treatment of patients with radiation-induced Xerostomia

    The objective of the phase I clinical trial was to evaluate safety and provide proof of concept for efficacy of allogeneic adipose tissue-derived mesenchymal stromal/stem cells (ASCs) injected into the major salivary glands in cancer patients with salivary glands damaged by irradiation.

    This trial provides the first results showing that treatment with an “off-the-shelf” allogeneic ASCs drug into the submandibular and parotid glands of patients with radiation-induced salivary gland hypofunction and xerostomia is safe and potentially effective.

    A significant and clinically meaningful increase in unstimulated and stimulated whole saliva flow rate was observed along with decrease in xerostomia and improved patient-reported quality of life.

    Full article link
    Intraglandular Off-the-Shelf Allogeneic Mesenchymal Stem Cell Treatment in Patients with Radiation-Induced Xerostomia: A Safety Study (MESRIX-II) – PubMed

  • Cell2Cure enters a collaboration agreement with Endeavour Cells ApS

    Cell2Cure enters a collaboration agreement with Endeavour Cells ApS

    Cell2Cure has entered a collaboration agreement with Endeavour Cells ApS, to collaborate on the preparation, conduct, management, and completion of an un-blinded phase I/II clinical trial in children with autism.

    The clinical trial title is “Effect of adipose derived mesenchymal stromal cells on autism and leaky gut syndrome”.

    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 early 2023.

  • Cell2Cure enters a sublicense agreement with Endeavour Cells ApS

    Cell2Cure enters a sublicense agreement with Endeavour Cells ApS

    Cell2Cure has entered a sublicense agreement with Endeavour Cells ApS, which will allow Endeavour Cells ApS to develop, manufacture and commercialize allogeneic adipose tissue-derived mesenchymal stromal/stem cells (ASCs) for the treatment of Autism Spectrum Disorder (ASD), Attention Deficit Hyperactivity Disorder (ADHD), Attention Deficit Disorder (ADD), and other heterogeneous neurodevelopmental disorders with or without gastrointestinal issues.

    The agreements include down- and milestone payments, and ongoing service, support, and management of the project on undisclosed commercial terms.

  • Collaboration agreement between Cell2Cure and Cbio A/S

    Collaboration agreement between Cell2Cure and Cbio A/S

    Cell2Cure has entered a collaboration agreement with Cbio A/S to establish Cell2Cure’s own GMP facility for production of adipose tissue-derived mesenchymal stromal/stem cell products (ASCs) in Cbio’s newly established and approved cell production facility, Transformervej 8, 2860 Søborg, Denmark.

    Cell2cure has a license from Rigshospitalet, Copenhagen, to a proprietary ASC production technology platform.

    C2C will in these new facilities further develop ASC product portfolio and continue clinical development programs for diseases with inflammatory, immunological and tissue/function re-generation components involved.

  • Allogeneic adipose tissue-derived mesenchymal stromal/stem cell (ASCs) in Phase II testing in Salivary gland re-generation

    Allogeneic adipose tissue-derived mesenchymal stromal/stem cell (ASCs) in Phase II testing in Salivary gland re-generation

    Patients with head-and neck cancer are often treated with radiation therapy. A side-effect to this life saving therapy is reduced salivary production which has serious consequences for mouth- and dental health and quality of life.

    Injection of ASCs directly into the salivary glands in a phase I clinical trial has proven safety and promising efficacy. The first of 120 planned patients has been enrolled and treated with ASCs in a double-blind placebo-controlled phase II trial in patients suffering from damaged salivary glands due to radiation-induced hyposalivation and xerostomia.

  • Completion of allogeneic adipose tissue-derived mesenchymal stromal/stem cell (ASCs) in a Heart failure trial

    Completion of allogeneic adipose tissue-derived mesenchymal stromal/stem cell (ASCs) in a Heart failure trial

    Heart failure is a serious condition with a high morbidity and mortality. The patient enrolment and 1 year follow-up has been finalized for all heart failure patients in the Danish Ischemic Heart Failure phase II Trial (81 patients), in the International multi-centre SCIENCE Ischemic Heart Failure Phase II Trial (133 patients) and in the Non-Ischemic Heart Failure Phase I-II Trial (30 patients).

    All safety and efficacy data will be ready for publication late 2021.

  • Allogeneic adipose tissue-derived mesenchymal stromal/stem cell (ASCs) in a lung transplantation trial

    Allogeneic adipose tissue-derived mesenchymal stromal/stem cell (ASCs) in a lung transplantation trial

    Lung transplantation is the ultimate treatment of patients with severe lung disease. However, the short- and long-term prognosis is still problematic due to immunological reactions towards the transplanted lung.

    The first patient has successfully been enrolled in the Chronic Lung Allograft dysfunction (Lung transplant rejection) phase I-II trial. The patients are randomized to a blinded treatment with intravenous infusion of either 100 million ASCs, 200 million ASCs or saline. A total of seven of the planned 30 patients have been enrolled without safety implications.

  • Cell2Cure is part of testing allogeneic adipose tissue-derived mesenchymal stromal/stem cell (ASCs) to reestablish nerve conduction in the heart

    Cell2Cure is part of testing allogeneic adipose tissue-derived mesenchymal stromal/stem cell (ASCs) to reestablish nerve conduction in the heart