From its original breakthrough in this science, “US-based Laboratory located in Miami, FL” brought together a team of world-leading biologic scientists.
“US-based Laboratory located in Miami, FL” has utilized an ongoing R+D program with the Center for Regenerative Medicine Clinic and clinic members of the AASCP (American Academy of Stem Cell Physicians). As a result we were able to maintain consistent improvement and experience our results with tens of thousands of patients.
“US-based Laboratory located in Miami, FL” established a fully FDA complient cGMP with a level ISO7 clean room laboratory.
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 after meeting the release criteria requirements. The specific release criteria parameters for the product administered in these treatments are:
Amniotic fluid is obtained from full term planned cesarean sections. At this stage of fetal development, amniotic fluid cons•ists 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 | Induces blood vessel formation |
| IL-8 | Polymorphonuclear leukocyte (PMN) attract interleukin-8 (IL-8) enhances epidermal wound healing |
| MCP-1 | Monocyte chemoattractant protein-I (MCP-1/CCL2) is one of the key chemokines that regulate migration and infiltration of monocytes/macrophages. |
| TIMP-1 | The glycoprotein is a natural inhibitor of the matrix metalloproteinases (MMPs), a group of peptidases involved in degradation of the extracellular matrix. In addition to its inhibitory role against most of the known MMPs, the encoded protein is able to promote cell proliferation in a wide of cell types, and may also have an anti-apoptotic function. |
| TIMP-2 | same as TIMP-1 |
| Angiostatin | Angostatin, a circulating inhibitor of angiogenesis. In vitro, angiostatin inhibits endothelial cell migration, proliferation, and tube formation, and induces apoptosis in a cell type-specific manner. |
| uPAR | urokinase plasminogen activator (uPA) and its receptor (uPAR) promotes matrix remodelin and wound healin |
| EGF | Epidermal growth factor (EGF) is a protein that stimulates cell growth and differentiation b bindin to its receptor, EGFR |
| IGFBP-1 | a member Of the insulin-like growth factor binding protein (IGFBP) family, IGF-binding proteins prolong the half-life of the IGFs and have been shown to ether inh ibit or stimulate the growth protnoting effects of the IGFs- This protein is important in cell migration and metabolism. |
| IGFBP-2 | same as above |
| IGFBP-4 | same as above |
| IL-9 | Acts as a regulator of a variety of hematopoietic cells. This cytokine stimulates cell proliferation and prevents apoptosis. |
| Osteopontin | OPN interacts with multiple cell surface receptors that are ubiquitously expressed thereby making it an active player in many physiological and patholoccal processes including wound healing, bone turnover, inflammation, ischemia, and immune responses. |
• 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 UBP-PM product to elucidate the regenerative compartments mediating our observed therapeutic effect.
• 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. Therefore, we have characterized these two distinctly and therapeutically important components.
• There is no addition or combination of any other substance of diluent to the AdiaVita product during production besides the cryopreservation solution dimethyl sulfoxide (DSMO)
• Each 1.0 ml Vial of AdiaVita is guaranteed to have > 100 million Stem Cells and > 3 Trillion Exosomes
*Adia Labs products are distributed for analytical testing and/or research use purposes or other Institutional Review Board (IRB) approved protocols or similar. The use with patients should include full disclosure and a signed consent form.
Donor Qualification – All donors of cord blood are consented and screened following FDA guidelines for donor qualification 21 CFR 1271.
All contract tissue recovery organizations working with “US-based Laboratory located in Miami, FL” hold their. approved IRB protocol. Human prenatal tissue is obtained solely through. voluntary donation using an IRB approved informed consent form.
Recruitment is performed only by the trained staff.
All staff members are trained on HIPAA guidelines.
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 research, ongoing clinical trials, or the potential applications of our therapies, please don’t hesitate to reach out. Whether you’re a healthcare professional, a patient, 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.
