Newcyte-UCT

About The Product

Umbilical cord contains Wharton’s jelly that is a rich source of mesenchymal stem cells, which give growth to many of the “support tissues” in the body, including bone, cartilage, fat and muscle. They also have the potential to develop into nerve cells and are known to have a positive impact in reducing inflammation. Umbilical cord is a preferred source of mesenchymal stem cells due to low immunogenicity levels and better transplantation success in allogenic transplants. Our product contains mesenchymal stem cells and is rich in growth factors from umbilical cord tissue. We acquire these tissues under informed consents and strict ethical protocols. These tissues are from safe, reliable hospital sources via a non-invasive, simple, and painless procedure.

Product name	Proprietary name(Brand name)	Specifications
Umbilical Cord Tissue Stem Cell Suspension (Volume sizes: 1 cc, 2cc, 3cc, 4 cc) Special order: 10 million per cc 20 million per cc 30 million per cc	Newcyte-UCT™	• Homologous use only • Allogeneic Umbilical Cord Tissue 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 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. • Cord Tissue will be received from an official registered Cord blood/Tissue bank. • For Therapeutics purposes only. • Rich source of Mesenchymal Stem Cells, Endothelial cells, Epithelial 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-UCT may aid in host repair and healing, beneficial for treatment of variety of diseases and injuries. • Ask your doctor whether you are qualified or not. • Active area of regenerative medicine • Cord Tissue 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. • Contains unique and powerful stem cells that may help repair and heal the body in different ways than cord blood. These cells create structural and connective tissue and are currently being evaluated in 30+ clinical trials to treat heart disease, stroke and spinal cord damage, among others. • FDA REGISTERED • HIPAA registered • Public Health Registered

Product name

Proprietary name(Brand name)

Specifications

Umbilical Cord Tissue Stem Cell Suspension (Volume sizes: 1 cc, 2cc, 3cc, 4 cc)

10 million per cc
20 million per cc
30 million per cc

Newcyte-UCT™

• Homologous use only
• Allogeneic Umbilical Cord Tissue 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 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.
• Cord Tissue will be received from an official registered Cord blood/Tissue bank.
• For Therapeutics purposes only.
• Rich source of Mesenchymal Stem Cells, Endothelial cells, Epithelial 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-UCT may aid in host repair and healing, beneficial for treatment of variety of diseases and injuries.
• Ask your doctor whether you are qualified or not.
• Active area of regenerative medicine
• Cord Tissue 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.
• Contains unique and powerful stem cells that may help repair and heal the body in different ways than cord blood. These cells create structural and connective tissue and are currently being evaluated in 30+ clinical trials to treat heart disease, stroke and spinal cord damage, among others.
• 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.

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