Umbilical cord blood is a rich source of hematopoietic stem cells that are similar to those found in the bone marrow and have the ability to develop into all the different blood cell types creating the blood and immune system. Hematopoietic stem cells are used for transplantation to reconstitute the blood and immune system in numerous malignant and non-malignant conditions like Leukemias, Fanconi anemia, Sickle cell disease, Thalassemia, Wiskott-Aldrich syndrome, Chronic granulomatous disease to name a few. Demand for umbilical cord blood transplants is increasing as the hematopoietic stem cells from umbilical cord blood are biologically naïve, more flexible and easily available as compared to bone marrow derived hematopoietic stem cells.
|Product name||Proprietary name(Brand name)||Specifications|
|Umbilical Cord Blood Stem cell suspension (Volume sizes: 0.5 cc, 1cc, 2cc, 3cc, 4cc)|
- 10 million per cc
- 20 million per cc
- 30 million per cc
- • Rich source of T-Cells
- • Homologous use only
- • Allogeneic Umbilical Cord Blood Stem cell.
- • Code of federal regulations: HCT/Ps 21 CFR 1271.3(c)
- • 4 X 106 cell per 1 cc
- • 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.
- • Multiple Quality control Tested. (Full report will be provided upon client’s request-Extra fee may apply)
- • Aseptically harvested cells
- • Donor eligibility:
- – Extensively Serologically tested for multiple infectious diseases/agents. Please refer to Certificate of analysis for list of infectious diseases panel we test each batch of blood.
- – 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
- • For Therapeutics purposes only.
- • Product integrity, quality and sterility are our only priorities.
- • Cord blood will be received from an official registered Cord blood bank.
- • Rich source of Hematopoietic Stem Cells.
- • 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.
- • The StemL-UCB may aid in host repair and healing, beneficial for treatment of variety of diseases and injuries.
- • Active area of regenerative medicine
- • Cord blood procured from live, healthy donors during childbirth.
- • Sterility of the product: Stemell cell harvested from cord blood in a fully controlled-sterile environment in a certified fully equipped Class 100 clean room.
- • Delivered in a very controlled packaging and environment due to temperature sensitivity of the product.
- • 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.|