The effectiveness of cryopreserved human umbilical cord blood nucleated cells (UCB-TNCs), cryopreserved allogeneic Placenta-Derived Multipotent Mesenchymal Stromal Cells (P-MMSCs), and cryopreserved human Amniotic Membrane (AM) alone and their combinations in Diabetic Peripheral Neuropathy, Peripheral Artery Lesions and Non-healing Diabetic Foot Ulcers

Stem cell-based therapy is a promising therapeutic strategy to treat Diabetic Foot Disease (DFD). Mesenchymal stem cells (MSCs) therapy has shown enhanced wound healing through increased angiogenesis, reepithelialization, and tissue granulation due to immunomodulatory properties, ability to synthesize and secrete cytokines which promote extracellular matrix remodeling, angiogenesis, neuroregeneration. Due to the above properties, MSCs transplantation can accelerate wound closure in diabetic foot ulcers (DFU), improve clinical parameters and avoid amputation

MSCs derived from placenta and umbilical cord blood are an ideal cell source for regenerative therapy with no ethical issues, which can provide easy, effective, and cost-efficient transplantation to treat DFU and protect patients from amputation

Amniotic membrane transplantation is a promising method of treating DFD due to the stimulation of own cytokines and biologically active molecules of healing and epithelization of diabetic ulcers

Study aim: assessment of the safety and effectiveness of the application of cryopreserved allogeneic Umbilical cord blood total nucleated cells (UCB-TNCs), cryopreserved allogeneic Placenta-Derived Multipotent Mesenchymal Stromal Cells (P-MMSCs), and cryopreserved allogeneic Amniotic Membrane (AM) alone and their combinations in Diabetic Peripheral Neuropathy, Peripheral Artery Lesions and Non-healing Diabetic Foot Ulcers versus standard treatment

Primary Endpoint:

  • Safety and efficacy of intramuscular injections of cryopreserved allogeneic UCB-TNCs, P-MMSCs and the application of cryopreserved allogeneic AM
  • Safety and efficacy of intramuscular injections of cryopreserved allogeneic UCB-TNCs, P-MMSCs and the application of cryopreserved allogeneic AM will be assessed by fixing clinical results and estimation of adverse events at follow-up visits every 3 months during 1 year after first administration
  • Major adverse events were adjudicated: hospitalization, tumor formation, amputation, death

Dosing regimen:

Application of allogeneic cryopreserved AM once a week (±3 days) for 12 weeks depending on wound healing. The serial intramuscular (calf muscle) multiple injections of allogeneic UCB-TNCs (target dose up to 300 x 106cells per limb) or allogeneic P-MMSCs (target dose up to 100×106cells per limb) alone or in combination with application of allogeneic cryopreserved AM. The systemic administration (1×106/kg body weight) of allogeneic UCB-TNCs or P-MMSCs in combination with serial intramuscular (calf muscle) multiple injections of allogeneic UCB-TNCs (target dose up to 300×106cells per limb) or P-MMSCs (target dose up to 100×106cells per limb)

No HLA matching or immunosuppression required

Effectiveness of cryopreserved human umbilical cord blood nucleated cells (UCB-TNCs), cryopreserved allogeneic Placenta-Derived Multipotent Mesenchymal Stromal Cells (P-MMSCs), and cryopreserved human Amniotic Membrane (AM) alone and their combinations in Diabetic Peripheral Neuropathy, Peripheral Artery Lesions and Non-healing Diabetic Foot Ulcers

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