Invitra Cord Blood Stem Cells

330-459-8000

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Invitra Cord Blood Stem Cells

PRODUCT DESCRIPTION

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 blood cells through the process of hematopoiesis

 

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.

 

 

CONTRAINDICATIONS

In order to reduce the risk of complications, Invitra Cord Blood Stem Cells should not be implanted in the presence of active infections.

 

 

TISSUE DISTRIBUTION
Invitra Cord Blood Stem Cells is distributed by Invitrx Therapeutics, Inc.

 

PROCESSING
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.

 

TISSUE STORAGE
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.

ADVERSE REACTIONS
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 postoperatively 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.

 

REGULATORY

  • 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

 

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