skip to Main Content

About Our Process

Regenerative medicine is a field that spans decades and comes in many different forms. Often, we are asked where our products come from and how we determine who is a candidate for donation?

New Life regenerative products are donated from consenting mothers at the time of delivery.  Following all AATB, FDA, and AABB requirements,  New Life’s regenerative medicine products are safely cultivated and meet the highest quality assurance standards.

1Prescreening

2Processing

3Distribution

prescreening

Prescreening

Regenerative tissue is obtained from an expectant mother who consents to donate her birth tissues. The collection process is painless and poses absolutely no threat to the mother or her child. Donors are identified through participating OB doctors who have deemed the mothers’ pregnancies as normal and without complication. The mothers provide full consent and undergo comprehensive panel testing to determine eligibility as well as a thorough medical and social screening.

The mother will also undergo a physical exam. To be eligible to donate tissue, mothers must also be free from any transmissible diseases, active malignancies, and sepsis or systemic infections. Donating mothers must also have no known high risk for HIV or Hepatitis.

processing

Processing

At delivery, tissues are safely collected by trained technicians. They are transported overnight to the processing facility. In addition to the serological testing in the prescreening process, culturing is performed regularly during processing. All products are retested post-processing to ensure the absence of bacterial and fungal pathogens.

During processing, a cryopreservative is introduced to the tissue to protect cell viability. Once packaged into vials, the products are sent to a third body testing facility to ensure sterility.

All products undergo a 14-day quarantine period. After 14 days, the product batches are randomly retested to demonstrate a continued absence of bacterial and fungal pathogens and are non-pyrogenic. A licensed medical director reviews all testing results before the products can be released for clinical use.

distribution

Distribution

New Life products are shipped to medical facilities in validated shipping containers containing enough dry ice to maintain the appropriate storage temperature.  Included in the shipping container are instructions for use, product stickers, and a tissue utilization report card to be filled out by the clinician. Additionally, the package will contain an application guide as well as a quality assurance form verifying that New Life checked each order for accuracy before departure.

Back To Top