inoCells Stem Cell Therapy
inoCells Stem Cell Therapy Product is a sterile suspension of autologous human endometrial stem cells that produces from uterus tissue of the patient. Tissue is processed in inoCells class A clean rooms. Freezing and storage is used before transfer of stem cells to the ART clinic for injection into the patient.
All of the primary studies on stem cell isolation methods, product preparation and quality testing are completed and validated.
Endometrial stem cells
The endometrium regrows from a 1-2 mm thickness after menstrual shedding to 14 mm 15 thickness in the secretory phase (i.e. luteal phase) of the menstrual cycle and is able to completely regenerate after parturition, and in postmenopausal female subjects when exposed to estradiol replacement therapy. The endometrium consists of two layers, the functionalis layer and basalis layer. The functionalis layer includes the upper two thirds of the glands surrounded by loose vascularised stroma. Being a germinal supplier for new functionalis layer replacement in each menstrual cycle the basalis layer is composed of the lower one thirds of glands, stroma and large vessels. The functionalis layer sheds monthly with menstrual blood arising from changes in hormone levels and is quickly reconstructed after menstruation. This huge regenerative ability suggests that the endometrium has a stem cell basis that supports the tissue maintenance/regrowth. Endometrial stem cells (EnSC) were located in the basalis and functionalis layers. EnSCs are easily accessible, low cost, have minimal ethical hurdle, low immunogenicity and/or low tumorgenicity. The EnSCs may be further characterised by one or more of the following plastic adherence, being fibroblast like, having multi-lineage differentiation potential, expression of classical mesenchymal stem cell surface markers (CD105, CD90, CD146) and stable karyotype in culture. The existence of stem cells within the endometrium was first described by Prianishnikov in 1978. Over the years, various cell populations have been detected that have the ability to regenerate the stroma such asepidermal stem cells, mesenchymal stem cells (MSCs)and endothelial stem cells. Due to their unique attributes, including their immunosuppressive characteristic in association with their capability to promote angiogenesis and vascularization, EnSCs utilizing be considered as a promising therapeutic approaches in the context of regenerative medicine. As mentioned endometrial MSCs (EnMSCs) have weak immunogenicity because they have low expression of HLA-ABC and negative for HLA-DR so they can be used to inhibit autoimmunity or adverse excessive immune reactions and therefore employed for treatment of autoimmune conditions, inflammation and organ transplantation, in the future. EnMSCs are also considered as a good choice for carrying out stem cell therapy for gynecological disorders, in particular some tissue damage that is hard to fix.
Stem Cell Banking
Stem cell banking is a method by which stem cells isolated from different tissues of the body are collected, proliferated and stored. After evaluation and confirmation, these cells are stored for subsequent therapeutic uses.
Short time Banking
Through a small biopsy tissue will be obtained from patients uterus and after cell isolation, these cells will be stored and preserved for ovarian injection in proper time for patients.
Long time Banking
Our goal is to create a stem cell biobank, with successful management and proper activity, for long-term storage of stem cells and its use for subsequent treatments of ovarian insufficiency patients. Establishing an appropriate biobank stem cells provides the basis for effective storage, quality control and assessment, long-term maintenance, and management.
Poor ovarian responders are eligible for receiving inoCells product. These patients are characterized by at least two of following criteria:
1) Advanced maternal age
2) Low number of oocytes after conventional ovarian stimulation protocol
3) An abnormal ovarian reserve test such as low antral follicle count (AFC) or low anti-Mullerian hormone (AMH) level