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.
Invitra ECM Suspension™ is intended for use as an I.V. infusion or to fill soft tissue defects or bone voids.
In order to reduce the risk of complications, Invitra ECM Suspension™ should not be implanted in the presence of active infections.
Invitra ECM Suspension™ is distributed by Invitrx Therapeutics, Inc.
Invitra ECM Suspension™ is a biological cellular product derived from the human umbilical cord and comes frozen in a vial or thermogold preservative. If the vial is open, do not use.
- Invitra ECM Suspension™ is intended for a single patient, one time use only.
- Once opened, Invitra ECM Suspension™ must be used immediately or discarded.
Invitra ECM Suspension™ 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 ECM Suspension™ in its original packaging at -80°C in cryogold. If cells are received in the nonfreezing preservative thermogold, then the cells cannot be stored and must be used within 24hrs of receiving.
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 ECM Suspension™ should be reported immediately to Invitrx Therapeutics.