Product Information

MAXALLO Cord Blood CD34+ Stem/Progenitor Cells

MAXALLO CTA is a flowable placental membrane tissue allograft designed for the use by physicians. It is for homologous use only that allows the physician freedom to make precise applications.


MAXALLO CTA has been prepared in accordance to FDA 361 Ruling and meets all of the screening protocols set by FDA.


list of MAXALLO CTA products ( physicians only ):


Item                                                    Legacy Catalog#    Format   Donor    Size

Cord Blood (CD34+, TNC, CFU*)    CBMX34-5Mil      Frozen    Single     5 million / 1 cc   

Cord Blood (CD34+, TNC, CFU*)    CBMX34-10Mil    Frozen    Single    10 million / 2 cc   

Cord Blood (CD34+, TNC, CFU*)    CBMX34-30Mil    Frozen    Single    30 million / 2 cc



Description


CONTRAINDICATIONS:

MAXALLO CTA should not be injected into the spinal canal, in vital organs (including the heart and other areas of the central nervous system), nor the circulatory system. This product is not intended to be used as a bone substitute. 

MAXALLO CTA should not be injected in active infections nor patients that have conditions that would cause substantial risk of using this product. 

MAXALLO CTA has not been tested in combination with other products.


INSTRUCTIONS FOR MAXALLO CTA:

MAXALLO CTA Must be used in accordance to professional and clinical judgment of the treating physician concerning patient care.



PREPARATION INSTRUCTIONS


  • DO NOT USE If the pouch is open or punched please mail back the package to MAXALLO for further inspection and verification.
  • Allow 15-30 minutes for thawing the allograft. this process can be expedite by holding the container in your hand. an alternative would be to gently mix the cells in a saline solution to break up any clumps
  • Aspirate MAXALLO CTA using a 22g or larger needle and syringe. Inject the allograft in the patient’s body part as seen fit by the physician or surgents.


NOTE: each Vial has been intended to be used for and on one patient immediately after preparation. MAXALLO CTA is intended for one time use only any remaining allograft must be disposed immediately. 

Stem cells happen to be Mono-Nuclear Cells or MNC: when you look at them under a microscope there is only one nucleus. Unfortunately, one of the most difficult aspects of stem cell biology is that you can’t identify a stem cell just by looking at it. 

There are other types of blood cells which are also MNC, such as nucleated red blood cells. The only proof that a cell is a stem cell comes from how it behaves when it multiplies.

Scientists have worked for years to develop various chemical stains which have a high affinity for stem cells. The best known marker for blood-forming stem cells is that they test positive for CD34, a protein found on the surface of stem cells. But, CD34+ counts are not an accurate measure of stem cells: CD34+ results vary between labs, they can vary within a single lab, and only 1-2% of the MNC that have CD34+ are actually stem cells.

The Total Nucleated Cell count or TNC is the test most often reported as a measure of the cell count after cord blood processing. The main advantage of measuring TNC is that the count is highly reproducible within and among labs, so it can be used accurately throughout the blood banking community. 

Even better, the TNC count can be automated with the use of a device called a flow cytometer.

At present Colony Forming Units or CFU are considered to be the best measure of whether stem cells are “viable”, or quite frankly alive. The TNC count includes both living and dead cells. 

In the CFU test a small portion is watched under controlled conditions to see if stem cells divide and form colonies. This used to be a subjective measure, but recently it has been standardized with technology to image the cells and count colonies in the image. 

The only remaining problem with the test is that it takes days for colonies to grow.