Generatx PG50X is a Stem Cells Allograft Tissue derived from the human placental and umbilical organ intended for post-surgical biological would covering and direct injection to fill soft tissue defects, bone voids, or rheumatoid arthritis.
This package contains Human Cellular and Tissue Based Products (HCT/P) as defined by US FDA 21 CFR Part 1271.
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.
The donor tissue has been determined eligible for transplantation by a licensed Medical Doctor according to the criteria listed in the Donor Eligibility section below
Generatx Medical Doctor has determined that the donor of the tissue contained in this product is eligible to donate tissue for transplantation and usage based on meeting the following criteria:
Donors are pre-screened through medical record review and evaluation of pre-natal tests
Generatx Medical Doctor 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 Generatx Medical Doctor and Director. Our Medical Director is also 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.
In order to reduce the risk of complications, PG50X should not be implanted or injected in the presence of active infection. In addition, this product should not be used for intravenous or intrathecal applications.
Although donor tissue is 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
All adverse reactions or outcomes that potentially involve the use of PG50X should be reported immediately to Generatx at (865) 657 – 8367.
Generatx PG50X Kit include:
- One Butterfly needle.
- One Vaccutainer Collection Holder.
- Four Tiger tops with clot activator and gel separator to obtain Serum.
- Four 25 G needles for injection.
- Four 18 G needles.
- Four 5 cc Syringes.
- Four alcohol pads.
- 2cc Activator ( solution A)
- 1cc PG50X (frozen form).
- One Poly-backed Blue Tissue Towel.
- One pair of Sterile Gloves.
- One Tourniquet.
Storage and Stability:
- The unopened PG50X must be stored in -80oC refrigerator or on dry ice.
- Once opened, PG50X must be used immediately or discarded.
- Generatx PG50X.
Materials Required But Not Provided:
- Centrifuge that can separate serum and red blood cells.
- Maintain PG50X must be stored in -80oC or on dry ice, DO NOT open till intended time of use.
- After opening the Kit place the products on a tray.
- Draw 4 tiger top tubes of patient blood and prepare PRP serum by spinning tube at room temperature at a speed of 1000 to 1300 RCF for 10 minutes in a swinging bucket centrifuge and 15 minutes in a fixed-angle centrifuge.
- Remove the PG50X vial and gently roll in palm of your hand till its all liquid.
- Draw 3cc of PRP into a provided syring.
- Add solution A to PRP syringe.
- Draw PG50X into PRP and solution A syringe.
- Inject PG50X, PRP and solution (A) into several points around and about the desired body part as needed.
- Wait for 30 minutes and then continue with Step below.
- Draw Remaining PRP into another unused 10 ml sterile syringe and inject directly to the same body site or any other body parts at physician discretion. Note some smaller sites like fingers joints may need much less amount in comparison to larger site knees.
- For small joints (finger) use 0.5-1.0 ml of solution (PRP+A+PG50X).
- For medium size joints (wrist and elbow) 2.0-2.5 ml solution (PRP+A+PG50X).
- For large joints (knee, shoulder) use 100% of solutions.
- For Pain sites (hips, back and neck and spine surgeries) 100% of solutions should be injected to several points of the location .
NOTE: This is needle guided injection and use of ultrasound or C-Arm is recommended.
These recommendations are designed only to serve as a general guideline. They are not intended to supersede institutional protocols or professional clinical judgment concerning patient care.
Do not use if the vial integrity has been violated, opened, or if mishandling has caused possible damage or contamination.
Store PG50X Kit on dry ice or -80oC refrigeration.
08.2012 Once the expiration date on the label has been reached, the allograft must be discarded.
Each allograft is intended for single patient on a single use occasion only.
Rx only Use is limited to specific health professionals (e.g. physicians).
AFTER — USE, HANDLE AND DISPOSE OF ALL UN– USED PRODUCT AND PACKAGING IN ACCORDANCE WITH ACCEPTED MEDICAL PRACTICE AND APPLICABLE LOCAL, STATE AND FEDERAL LAWS AND REGULATIONS.