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AmeraCell only accepts bio-ethically donated birth tissue from healthy consenting mothers who

have passed a comprehensive medical background check, blood screenings, and are full-term,

live, C-section births. In addition, we only work with tissue procurement organizations within the

United States who use collection techniques that follow AATB guidelines, prioritizing the health

and safety of the mother and baby above procurement.

Lab Testing Guidelines: AmeraCell Tests 20% of Every Batch

AmeraCell American FDA Registered Human Cell Tissue Product

AmeraCell & USP 71 Sterility Guidelines All fungus, Mold, Yeast, Bacteria in accordance with AATB & FDA Endotoxin guidelines in accordance with AATB & FDA

Viruses and Blood and Tissue borne pathogens in accordance with AATB & FDA

The donating mother is tested the day of delivery for any blood borne illnesses.

is a minimally manipulated, bio-ethical human umbilical cord harvested product from

donated human tissue manufactured under GTP, cGMP, AATB and FDA HCT/P 361

guidelines. AmeraCell Cellular Products are DMSO free, and our proprietary process is absent of

harmful enzymes and chemicals to preserve integrity.

We Truly Have The Safest Superior Cellular American Tissues Product

AmeraCell Holds the Highest Standards for Our Life Science Products We Screen For

Acquired Immunodeficiency Syndrome

Mixed Connective Tissue Disease

Collagen-Vascular Disease

Lupus

Rheumatoid Arthritis
Scleroderma

Wegener’s Granulomatosis

Sarcoidosis

Psoriatic Arthritis

Autoimmune Diseases

Cancer

Chagas Disease

Prion Disease

CJD (Creutzfeldt-Jakob Disease)

Inflammatory Bowel Disease

Meningitis

AmeraCell Accessible Affordable American & Safe Life Science Products Additional Testing

E.Coli

Clostridium Species

Pseudomonas Aeruginosa

MRSA / VRE Isolate testing

Dementia

Degenerative Neurologic Disorders

Insulin Dependent Diabetes

Kaposi’s Sarcoma

Malaria

Bacillus Subtilis

Candida Albicans

Aspergillus Brasiliensis

Lyme Disease

Active Viral, Bacterial or Fungal

Infections

Anencephalic

Multiple Sclerosis

Mycosis

Melanogenesis

Transmissible Spongiform

Encephalopathy

Trisomy

Marfan’s Disease

AmeraCell Accessible Affordable American Stem Cell Clinics

Q: What is a structural tissue?

A: Tissues that physically support or serve as a barrier or conduit, or connect, cover, or cushion in the donor are generally considered

structural tissues for the purposes of determining the applicable regulatory definition. Examples of structural tissues include: Bone Skin Amniotic membrane and umbilical cord; Blood vessel; Adipose tissue; Articular cartilage;Non-articular cartilage tendons and ligaments

Q: What are the meaningful characteristics of structural tissue?

A: Structural tissues utility for reconstruction, repair, and replacement uses the original relevant characteristics of structural tissues

such as support, strength, flexibility, cushioning, covering, compressibility.

Q: Do these structural tissues contain cells?

A: Structural tissues may contain both extracellular matrix and cellular components because any alteration of these components

that relates to the structural tissue’s utility for reconstruction, repair, or replacement would generally be considered more than mini-mal manipulation.

Q: What’s Minimal Manipulation?

A: For structural tissue, processing that does not alter the original relevant characteristics of the tissue relating to the tissue’s utility

for reconstruction, repair, or replacement.

Q: What is Homologous Use?

A: Homologous use means the repair, reconstruction, replacement, or supplementation of a recipient’s cells or tissues with an HCT/P

that performs the same basic function or functions in the recipient. Recipients Cells or tissues may or may not be identical to the

donor cells or tissues but may perform one or more of the same basic functions in the recipient cells or tissues performed in the

donor. An HCT/P may perform the same basic function or functions even when it is not used in the same anatomic location where it

existed in the donor.

Citation: Source: Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use.

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