inoCell has successfully concluded its preclinical studies. In these preclinical Proof-of-Concept studies, no sign of toxicity and or other safety issues were found.
In vitro study
Endometrial Stem Cell isolation, culturing and differentiation were done in different culture mediums. In a set of chain studies, in vitro differentiation of endometrial stem cells into adipocyte, osteoblast and chondrocyte cells, neural cells, oligodendrocyte cell, schwann cells, oocyte cells, hepatocyte cells, pancreatic cells, myocyte cells, endothelial cell was performed. Several in-vitro studies showed that human endometrial stem cells can be expanded for several times and after long-term expansion, these cells retain normal karyotypes and epigenetic stability. They maintain greater than 50% of telomerase activity even at passage 12 compared with that in human embryonic stem cells.
In vivo study
Animal studies showed safety, stability, viability of endometrial stem cells in ovary tissue. Carcinogenicity and tumour formation assay for human endometrial stem cells were studied in animal models. There has been no evidence of teratoma, ectopic formation or any immune response after transplantation into an animal model. The plasticity and safety of the acquired cells have also been demonstrated.
In 2021, an in-patient study was performed on three patients. In this trial, patients with ovarian insufficiency were injected with inoCells product. Results showed that one case got natural pregnancy after six months which led to live and healthy birth. In all cases AMH level, E2 level, antral follicle number in both ovaries and the size of both ovaries increase significantly. Moreover, the FSH levels decreased in all three patients.