Stem Cells Source
What is the range of Chara Biologics’ products?
Chara Biologics offers advanced regenerative medicine products, including CharaCore®, a cryopreserved, umbilical cord–derived cellular product. It combines components from cord blood, cord tissue, and amniotic membrane, making it naturally rich in mesenchymal stem cells (MSCs), growth factors, and signaling molecules that support the body’s repair processes.
What makes CharaCore® different from other stem cell products?
CharaCore® is an umbilical cord–derived tissue product designed to support regenerative therapies. Compared to traditional autologous stem cell sources (using a patient’s own fat, bone marrow, or blood), it offers several important advantages:
Sourced From Healthy,
Full-Term Births
Cells are obtained from ethically donated birth tissues, ensuring high quality without invasive procedures.
More Biologically Active Cells
These cells are more primitive, with higher metabolic activity, faster self-renewal, and a broader ability to develop into specialized cell types.
Enhanced regenerative potential
They secrete higher levels of growth factors and cytokines, which play a key role in healing, repair, and cellular communication.
Reduced Cellular Aging
With longer telomeres and fewer accumulated environmental damages, these cells remain functional and effective longer than adult-derived cells.
Strong Anti-Inflammatory and Neuroprotective Properties
Beneficial for supporting the body’s natural response to injury and degeneration.
No Invasive Harvesting Required
Avoids the risks associated with extracting stem cells from the patient, such as infection, discomfort, or reduced personal stem cell reserves.
Consistent Quality for All Patients
Even individuals who are older or dealing with chronic conditions can access high-quality stem cells.
Flexible Treatment Applications
Allows for controlled, repeat dosing at precise concentrations tailored to individual needs.
Manufactured to Strict Standards
Chara products are processed in an FDA-registered, inspected laboratory that follows current Good Manufacturing Practice (cGMP) guidelines, ensuring a high level of safety, consistency, and quality.
Quality
CharaCore® is designed with a strong focus on quality, potency, and consistency:
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High concentration of MSCs
More than 20% of the total cell population consists of mesenchymal stem cells (MSCs), a key indicator of regenerative potential. -
Proven cell viability and function
Chara Biologics has achieved positive CFU (Colony-Forming Unit) assay results, demonstrating the presence, viability, and health of functional MSCs. -
Strict donor standards
All donors are U.S.-based and undergo highly rigorous screening and selection processes to ensure safety and quality. -
Comprehensive tissue utilization
CharaCore® is uniquely processed from the entire umbilical cord—including cord blood, cord tissue, and amniotic membrane—allowing it to harness the full regenerative potential of multiple tissue components.
Safety & Eligibility
Birth tissue–derived cells, such as those found in CharaCore®, are considered immunoprivileged. These young, primitive cells lack certain surface markers (HLA Class II) typically responsible for triggering immune responses, while still expressing markers that identify them as human cells.
Because of these properties, they are widely studied and used in regenerative medicine with a strong safety profile.
Donor Screening & Ineligibility
Chara Biologics follows strict donor screening protocols to ensure only the highest-quality and safest tissue is used. Any donor presenting elevated risk factors is excluded.
Key disqualifying factors include:
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History of infectious diseases such as HIV, Hepatitis B or C, or syphilis
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High-risk behaviors (e.g., non-medical injection drug use, high-risk sexual exposure)
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Recent exposure to bloodborne pathogens or contaminated instruments
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Certain medical conditions, including neurological diseases of unknown origin or prion-related risks (e.g., CJD)
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Recent incarceration or exposure to environments with increased infection risk
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Unsafe tattooing or piercing practices
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Certain travel, residency, or transfusion histories associated with elevated disease risk
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Exposure to emerging infectious diseases (e.g., West Nile Virus, Zika, Ebola)
Additional medical and family history reviews are conducted for:
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Autoimmune disorders
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Blood diseases or metabolic conditions
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Neurological conditions
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Other factors that could impact cellular quality
All donors must pass an extensive medical, social, and laboratory screening process before being approved.
Comprehensive Testing & Quality Control
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Every donated tissue sample undergoes rigorous laboratory testing to ensure safety and purity.
Infectious disease screening includes:
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HIV Types I & II
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Hepatitis B & C
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Syphilis
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HTLV
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West Nile Virus
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Zika Virus
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Cytomegalovirus (CMV)
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Lyme disease
Microbial and contamination testing includes:
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Bacterial screening (e.g., E. coli, Staphylococcus aureus)
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Fungal and yeast testing
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MRSA and VRE screening
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Additional organism-specific testing
Any tissue testing positive for harmful microorganisms is automatically rejected.
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Tissue Processing & Release Standards
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Tissue cultures are evaluated at the time of procurement
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Products are quarantined post-processing until all testing is complete
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Only tissue that passes strict safety and quality benchmarks is approved for use
Advanced Sourcing Standards
Chara Biologics utilizes a highly controlled and ethically guided sourcing process:
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All donors are U.S.-based and pre-screened
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Donor health is carefully monitored prior to donation
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Additional measures are taken to support maternal health and optimize tissue quality
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Proprietary processing techniques help maintain cell viability and function after thawing