Allograft Tissue Information and Product Preparation
Contents / How Supplied
This package contains Human Cellular and Tissue Based Products (HCT/P) as defined by US FDA 21 CFR Part 1271.
The donor tissue has been determined eligible for transplantation by a licensed Medical Director according to the criteria listed in the Donor Eligibility section below.
In order to reduce the risk of complications, Invitra Cord Blood Stem Cells should not be implanted in the presence of active infections.
Invitra Cord Blood Stem Cells is distributed by Invitrx Therapeutics, Inc.
Invitra Cord Blood Stem Cells is a biological cellular product derived from the human umbilical cord and comes frozen in a vial. If the vial is open, do not use.
- Invitra Cord Blood Stem Cells is intended for a single patient, one time use only.
- Once opened, Invitra Cord Blood Stem Cells must be used immediately or discarded.
- Contains cells extracted from umbilical cord blood containing a mixed cell population including hematopoietic (HSC) and mesenchymal stem cells (MSC).
- MSCs: multipotent stromal cells that can differentiate into a variety of cell types, including: osteoblasts , chondrocytes, myocytes and adipocytes.
- HSCs: give rise to all other bloodcells through the process of haematopoiesis
Invitra Cord Blood Stem Cells is processed by Invitrx Therapeutics, Inc. The HCT/Ps are processed in a controlled environment using methods designed to prevent contamination and cross-contamination of the products. Technical quality assurance standards are rigorously maintained.
It is the responsibility of the end user to document and maintain Invitra Cord Blood Stem Cells in its original packaging at -80°C. If cells are received in the nonfreezing preservative thermogold, then the cells cannot be stored and must be used within 24hrs of receiving.
- Mixed cell population cell count of 5 million cells per mL
- Offered in .25, .50., 1.0, 2.0, 3.0, 4.0 mL
- U.S. UCB donors
- UCB is tested for for HIV1/2, HbsAg (HBV), HCV, HBHCV/HBV Ultrio (NAT testing), and CMV.
- Verification of sterility through utilization of microbial testing.
The Medical Director has determined that the donor of the tissue contained in this product is eligible to donate tissue for transplantation based on meeting the following criteria:
- Donors are pre-screened through medical record review and evaluation of pre-natal tests
- Medical Director confirms eligibility through
- Behavioral risk assessment
- physical assessment
- Donor medical history
- Review of blood test results
- Communicable disease testing
At the time of recovery, cultures of the tissue are taken and grown out for evaluation. Discussions with physicians and /or the donor mother are conducted to identify circumstances that may lead to the exclusion of the donor or donated tissue. The blood sample test results, donor medical history, behavior risk assessment, physical assessment, and information from other sources or records, which may pertain to donor suitability, have been evaluated by a Medical Director. The Medical Director is a licensed physician who completes a comprehensive review of every donor record. The results are used to determine that the donor suitability criteria at the time of tissue recovery have been met, and that the tissue is acceptable for transplantation.
Although donor cells are evaluated and processed, the donor screening methods are limited and may not detect all diseases. As with any grafting procedure, complications at the graft site may occur post operatively that are not readily apparent. These include, but are not limited to:
- Transmission of diseases of unknown etiology
- Transmission of unknown infectious agents such as viruses, bacteria and fungi
- Immune rejection of or allergic reaction to implanted HCT/P
Adverse reactions or outcomes that potentially involve the use of Invitra Cord Blood Stem Cells should be reported immediately to Invitrx Therapeutics.
- Umbilical Cord Blood is recognized as a HCT/P (human cells, tissues, and cellular and tissue-based products) by the FDA
- HCT/P’s Regulated under 21 CFR 1271.3(d)(1) and Section 361 of the PHS Act
- Invitrx Therapeutics is registered with the FDA and holds a CA tissue bank license allowing for the storage and distribution of Invitra CBSC Suspension