Our revolutionary LiveCyte™-TX products can be used intraoperatively or through injection therapies to integrate with injured tissue and promote a regenerative healing environment.
|Product name||Proprietary name(Brand name)||Specifications|
|Amniotic Tissue Stem Cells Complex. (Extracellular Membrane Substance) Volume sizes : ( 1cc and 2 cc)||Newcyte-TX|
- • Homologous use only
- • Allogeneic
- • Rich source of Stem cell.
- • Code of federal regulations: HCT/Ps 21 CFR 1271.3(c)
- • Precisely and carefully counted using fully automated state of the art equipment (s) (Full quantitative report will be provided per delivery)
- • Quality Assurance and Quality Control form a significant part of the testing that we do at Stemell.
- • Donor eligibility:
- -Extensively Serologically tested for multiple infectious diseases/agents. Please refer to Certificate of analysis for list of infectious diseases panel we test every cord tissue.
- – Donor Medical history, physical assessment, behavior assessment review by a medical director before the batch release.
- • The Donor eligibility determines by a Medical director by reviewing
-Behavioral risk assessment
- • Product integrity, quality and sterility are our only priorities.
- • Amniotic Tissue will be received from an official registered Cord & Amniotic Tissue bank.
- • For Therapeutics purposes only.
- • Rich source of different type of Mesenchymal Stem Cells-. (Usually less than Cord Tissue cells overall)
- • Rich source of nutrients and antibodies (cells in the body that fight off infection)
- • Disease testing report will be provided to the Medical/Health care professional.
- • Active area of regenerative medicine
- • Delivered in a very controlled packaging and environment due to temperature sensitivity of the product.
- • Uniquely cryopreserved and freeze the cells using a U.S patented, GMP and clinically graded cryopreserved solutions in order to exponentially minimize or potentially eliminate the elements that would damage the cell viability and reduce the cell quantity after thaw the cells before transplantation.
- • FDA REGISTERED
- • HIPAA Registered
- • Public Health Registered.
|Quality Control Specifications||Test*||Specification|
|Sterility (fungi, yeast, bacteria)||No growth|
|Mycoplasma contamination||None detected|
|pH||7.5 ± 0.05|
|Osmolality||276 ±10 mOsm/Kg|
|Cell culture test||Linear signal across a 1000-fold range of cells|
|*Please consult the Certificate of Analysis for lot-specific test results|
|Functional Testing||Newcyte is performance tested to generate a linear fluorescent signal across a 1000-fold range of adherent mammalian cells.|