AdiaVita the Most Trusted Brand™
AdiaVita the Most Trusted Brand™
Disclaimer: This page contains content specific to Florida Stem Cell Law, which allows specific licensed physicians to administer stem cell therapies that the U.S. Food and Drug Administration has not approved. The law and the content apply to providers licensed in Florida under Chapter 458 (Medical Doctors) and Chapter 459 (Osteopathic Physicians) acting in the course and scope of their employment
From its original breakthrough in this science, our researchers brought together a team of world-leading regenerative biologic scientists. Our laboratory, in collaboration with numerous regenerative medicine clinics and an academy of stem cell physicians, has had the opportunity to observe and refine our results through the treatment of tens of thousands of patients.
Our laboratory has established the status as a fully FDA compliant cGMP facility with a level ISO7 clean room.
All manufacturing is performed by qualified, trained scientists under cGMP laboratory with an ISO7 clean room. Release criteria including sterility is tested by independent third party labs.
The raw amniotic fluid is collected by FDA-approved and AABB accredited cord-blood banks within the USA and shipped overnight to our labs. Mothers are consented and tested for infectious diseases and other exclusion criteria at the time of normal full term pregnancy in situation of planned delivery by C-section.
Using proprietary techniques, requiring minimal manipulation of the material, raw amniotic fluid is transformed into AdiaLink. The vials are quarantined for 14 days while lots are tested by independent labs for sterility and endotoxin. We have a 100% clean record over the years that our scientists have been producing AdiaVita and AdiaLink.
Vials are shipped on dry ice within tamper-proof insulated shippers, together with product details and a certificate of analysis. Prior to shipment the vials are stored in a -80c degrees freezer. The cryovials are never submerged in the liquid phase of liquid nitrogen.
AdiaLink is derived from human amniotic fluid donated from consenting adults during routine, planned cesarean sections under IRB approved donor screening. AdiaVita is derived from Umbilical Cord blood.
Donor qualification was performed under FDA CFR 1271. Donor qualification was certified following the review of the mother’s medical history, social history, physical examination, and raw product recovery information.
Relevant communicable diseases are tested and the mother is reported to have negative/non-reactive results for:
The collected amniotic fluid is subjected to centrifugation and proprietary filtration to remove large particle debris and preserve the natural protein, nanoparticle, and exosome composition of amniotic fluid. The final product is released only after meeting stringent release criteria, including the following specific parameters:
Amniotic fluid is obtained from full term planned cesarean sections. At this stage of fetal development, amniotic fluid consists of water (98-99%), salts to maintain proper osmolarity, proteins and enzymes to aid in fetal growth. To address the protein composition of our product, we performed arrayscan analysis using a commercially available Human Cytokine Array (RayBiotech AAH-CYT-5-8) which detects 80 different cytokines. Table 1 lists the cytokines in greatest abundance, defined as having a value greater than 1 (baseline) on an arbitrary scale defined by the kit manufacturer. The listed cytokines all have functions relating to tissue repair and remodeling:
Our product is unadulterated; following procurement, the amniotic fluid is not mixed or diluted with any additional components. We have evaluated the composition and characteristics of the final product in reference to original unprocessed amniotic fluid using both proteomics (Mass Spec) and the same human cytokine array kit used to generate the data shown in Table 1.
| Cytokine | Function |
| Angiogenin | A ribonuclease family protein associated with cellular RNA processing and angiogenesis-related signaling pathways in tissues. |
| IL-8 | A chemokine (CXCL8) involved in immune cell chemotaxis and neutrophil activation, playing a role in inflammatory signaling cascades. |
| MCP-1 | Also known as CCL2, a chemokine that participates in monocyte recruitment and immune trafficking within the extracellular environment. |
| TIMP-1 | A glycoprotein that binds to matrix metalloproteinases (MMPs), regulating extracellular matrix turnover influencing cell-matrix interactions. |
| TIMP-2 | Similar to TIMP-I, a metalloproteinase inhibitor involved in modulating ECM degradation and cellular remodeling processes. |
| Angiostatin | A plasminogen-derived fragment associated with endothelial cell regulation and vascular homeostasis in physiological contexts. |
| uPAR | The urokinase plasminogen activator receptor, which facilitates plasminogen activation and contributes to cell adhesion and migration signaling. |
| EGF | Epidermal growth factor, a ligand that binds to EGFR receptors, influencing cellular proliferation and differentiation pathways. |
| IGFBP-1 | An insulin-like growth factor binding protein that modulates IGF bio-availability, affecting cell growth signaling and metabolic regulation. |
| IGFBP-2 | Similar to IGFBP-1, a binding protein regulates IGF interactions and supports cellular metabolic processes. |
| IGFBP-4 | Similar to IGFBP-1, involved in IGF modulation and cellular homeostasis. |
| IL-9 | A cytokine that interacts with hematopoietic cells, contributing to immune cell development and cytokine network regulation. |
| Osteopontin | A multifunctional glycoprotein (OPN) that binds integrins and CD44, participating in cell adhesion, migration, and extracellular dynamics. |
• Description: UCB-PM is an allogeneic, minimally manipulated product derived from allogenic umbilical cord blood collected from normal healthy planned cesarean section donors. We have completed extensive characterization of the final UCB-PM product to analyze its biological components for research purposes.
• AdiaVita’s manufacturing methodology is designed to preserve the naturally-occurring soluble proteins and nanoparticles including exosomes present in full-term cord blood UCB-PM. These components have been characterized for their biological properties in research settings.
• There is no addition or combination of any other substance of diluent to the AdiaVita product during production besides the cryopreservation solution dimethyl sulfoxide (DMSO)
• Each 1.0 ml Vial of AdiaVita is guaranteed to have > 100 million Stem Cells and > 3 Trillion Exosomes
Adia Labs products are distributed exclusively for analytical testing and/or research use purposes or other Institutional Review Board (IRB) approved protocols or similar. Any clinical use must comply with applicable FDA regulations, including informed consent and full disclosure to patients.
Donor Qualification – All donors of cord blood are consented and screened following FDA guidelines for donor qualification 21 CFR 1271.
Donor population is recruited indiscriminately of ethnic group; however, the donor eligibility is limited to the age range of 18-45 years old due to the aging related quality of human prenatal tissue. The donor must be tested negative. for communicable diseases (listed below) and pass the screening on the social and health history questionnaire and be determined not to be in the high-risk category.
Donors for whom donor eligibility has not been completed in accordance with the 21 CFR 1271 regulations (specifically donor screening) will not be eligible and material will be disposed per SOP# CFRM-DOC-037.
This process is performed to prevent transmission of communicable disease• as dictated by 21 CFR, 1271 subpart C—Donor Eligibility.
Donor will undergo the following procedures and tests after the, Laboratory Testing Report of Infectious Disease:
1. Sign the Informed Consent Form
2. Complete physical medical check-up
3. Complete Medical and Social History Interview
The following communicable infectious diseases will be tested,
including gonorrhea and clamydia:
1. Hepatitis B surface antigen (HBsAg)
2. Chagas disease (through a T. cruzi ELISA test)
3. Anti-Hepatitis C virus antibody (HCV Ab)
4. Anti-Human Immunodeficiency Virus (HIV) antibody (HIV 1/2)
5. Cytomegalovirus antibody (CMV)
6. HIV/HCV Nucleic Acid test (HIV1/HCV/HBV NAT)
7. West Nile Virus Nucleic Acid test (WNV NAT)
8. Syphilis Screening Nontreponemal
9. Human T-lymphotropic Virus I/II (HTLV I/II)
10. Zika Virus (NAT) if applicable*
11. SARS-CoV-2: if applicable after known or suspected exposure*
The blood specimens for testing are collected within 7 days of recovery of
cord blood from the donor. All infectious disease testing is performed by a
laboratory certified to perform such testing on human specimens under the
CLIA or that has met equivalent requirements as determined by, Testing
Laboratory CLIA Certification). All kits used by testing lab are FDA
approved. All donors are screened by reviewing relevant medical records
for risk factors for, and clinical evidence of, relevant communicable
disease agents and diseases.
Questions to identify persons at risks of infectious disease transmission including Zika virus and SAR CoV-2 in accordance with
the 21 CFR 1271 regulations (specifically donor screening) will not be eligible and material will be disposed per internal policies.
Safety assessment is completed by performing endotoxin and 14-day sterility testing for the detection of bacteria, fungus, and yeast contamination. Endotoxin tests are completed in accordance with USP<85> guidelines and sterility tests are performed by VRL Eurofins, a qualified CLIA-certified laboratory, in accordance with USP<71> guidelines.
One vial is selected for endotoxin testing and 10% of the total lot volume is randomly selected for 14-day sterility testing at the completion of the manufacturing procedure.
The vial sample size selected for 14-day testing is determined by the USP<71> guidelines for the minimum volume and containers required based on total lot production size.
Furthermore, in-process samples are collected for 14-day sterility analysis at the beginning of cord blood handling (Raw product sample) and prior to adding DMSO as a pre-cryopreservation sample. Our release criteria for safety assessment states that endotoxin levels must be below 5 EU/ml and all samples must be negative for sterility.
If you have any questions about our laboratory research, product development, release criteria, or the scientific applications of our regenerative biologics, please don’t hesitate to reach out. Whether you’re a researcher, healthcare professional, or simply curious about the possibilities of regenerative medicine, our team is here to provide you with the information you need. Please fill out the form, and one of our specialists will get back to you as soon as possible.
While many of Adia’s Products are not yet FDA-approved, it’s important to understand that off-label use is legal and standard in U.S. healthcare. The FDA regulates drug manufacturers—not the practice of medicine. Physicians can legally use approved biologic products (like umbilical cord stem cells) off-label when they believe it is in the best interest of the patient.
