The source material — Wharton’s Jelly from cord donations — is obtained exclusively from accredited medical centers in compliance with Ukrainian law. Donor informed consent is obtained and stored at the corresponding medical centers where procedures are performed. Donors are not compensated, ensuring that all donations are entirely voluntary and fully ethical. Prior to the procedure, each donor’s health status is thoroughly assessed to exclude common viral infections and conditions that could affect the genetic integrity of the stem cells, as well as to confirm the absence of genetic abnormalities. All donors are tested for HBsAg, HIV I&II, HCV, and syphilis using immunochromatographic tests. In addition, every sample of source material is accompanied by the donor’s blood for further PCR testing.
Our laboratory in Ukraine follows Good Manufacturing Practice (GMP) — the highest international standard for medical-grade production. This framework guarantees that every stem cell batch is consistent, pure, potent, and safe for use in humans.
We use clinically approved cultivation media, which is essential for safety. This ensures freedom from contamination, consistent quality, and full compatibility of our cells with clinical applications.
Preconditioning strategies include exposure to hypoxia, growth factors or cytokines, and co-cultivation or conditioned media. We apply these approaches to cultivate highly effective mesenchymal stem cells (MSCs) and enhance their therapeutic potential, tailoring them to specific regenerative goals across a wide range of diseases.
We use stem cells at early passages. At this stage, cells retain their full therapeutic potency, remain genetically stable, and have the lowest risk of unwanted changes. Each batch undergoes strict testing for sterility and quality control.
We have developed a unique automated cryopreservation program, ensuring more than 95% post-thaw viability of our cell products. This technology preserves the integrity, functionality, and therapeutic potential of the cells, providing a reliable supply for clinical use without compromising safety or quality.
Proper storage is essential to preserve the quality and safety of mesenchymal stem cell products over the long term. The most common methods include low-temperature freezers at -80°C or liquid nitrogen at -196°C. These precise conditions ensure that every dose remains fresh, viable, and ready to support regeneration.
Proper shipment is essential to ensure the quality and safety of EmCell stem cell preparations for treatment at our Antigua and Barbuda center. We use a trusted international transportation company experienced in handling cryobiological materials.
Cells are transported in specialized cryo vapor shippers, which maintain temperatures between -140°C and -196°C using liquid nitrogen safely contained in an absorbent material. Temperature is continuously monitored with data loggers and visual indicators to guarantee that the cells remain stable and fully viable during transit. This approach ensures safe, compliant air transport while preserving the therapeutic potential of EmCell stem cell products.
We receive our Mesenchymal Stem Cells from a state-of-the-art GMP-compliant laboratory in Ukraine, which has been producing high-quality stem cell preparations for more than 30 years. The laboratory complex spans 8,600 sq ft and includes a GMP Biotechnology Laboratory, PCR Laboratory, Microbiology Laboratory, R&D Laboratory, Quality Control Laboratory, and Cryobank. All facilities operate under strict international standards to ensure the safety, quality, and efficacy of every product.
The 1,600 sq ft GMP Biotechnology Laboratory is equipped with five isolated GMP Grade B clean rooms, each with Grade A biological safety cabinets, and features continuous environmental monitoring for sterility, pressure, temperature, humidity, and airborne particles. Every stage of production undergoes rigorous equipment qualification, validation, and verification, supported by a certified quality management system. Personnel receive continuous training and monitoring to ensure strict adherence to hygiene, sterilization, and cleanroom protocols. All stem cell preparations are manufactured in full compliance with GMP and European Pharmacopeia standards for clinical use.
Every stem cell preparation undergoes thorough safety checks before, during, and after processing. All procedures are conducted in our laboratories under strict Good Manufacturing Practice (GMP) standards, ensuring that each product is safe, reliable, and of the highest clinical quality.
Initial screening takes place at the donation stage. Accredited medical centers conduct donor assessments for common viral infections and conditions that could affect the genetic integrity of the source material. This minimizes the risk of genetic abnormalities in the final preparation. Donor blood is tested for viral infections, including HCV, HBV, and HIV 1/2, using PCR methods to ensure complete viral safety.
Each stem cell preparation undergoes rigorous microbiological sterility checks. The first test is performed on the source material, and throughout the expansion process, every WJ-MSC preparation is repeatedly tested for sterility. Testing is conducted using the FDA-approved BacT/ALERT 3D 120 automatic colorimetric system (bioMérieux, France), which detects aerobic, anaerobic, and facultative anaerobic microorganisms, as well as yeasts and fungi. Additionally, mycoplasma testing using a PCR-based method is performed to ensure the absence of these microorganisms, which can affect cell growth and function.
Each EmCell mesenchymal stem cell preparation is tested in our ISO 15189-certified PCR laboratory using real-time PCR for 18 different infections, including HCV, HBV, HIV 1/2, EBV, CMV, HHV6, HSV 1/2, HPV, SARS-CoV-2, Parvovirus B19, Treponema pallidum, Chlamydia trachomatis, Mycoplasma hominis/genitalium, and Ureaplasma parvum/urealyticum.
Mesenchymal stem cells (MSCs) have an inherently low risk of tumor formation due to their limited self-renewal and differentiation capacity. Our MSC products undergo thorough testing before each lot release to ensure there is no risk of tumorigenicity.
To further minimize potential risks, we implement rigorous source cell screening, regular karyotype analysis, surface marker verification (CD73, CD90, CD105), optimized culture protocols, and careful monitoring of patients. These measures collectively ensure the highest standards of safety for every MSC treatment.
Each batch undergoes thorough quality control to guarantee high-quality, clinically ready MSCs, fully optimized for safe and effective regenerative therapy.
Each batch of EmCell mesenchymal stem cell preparation undergoes thorough visual and microscopic inspections by our specialists to assess cell morphology and homogeneity. Preparations are carefully examined for the absence of aggregations, artifacts, and inclusions. Daily monitoring using an inverted microscope ensures consistent cell quality, uniformity, and integrity throughout the culture process, supporting the production of safe and effective MSC products.
EmCell mesenchymal stem cell preparations undergo characterization and viability assessment through immunophenotyping using a flow cytometer. This step allows us to confirm the number of live stem cells in each preparation. MSCs are identified using positive markers CD73+, CD90+, CD105+, and by the absence of CD34-, CD45-, HLA-DR-, in accordance with ISCT criteria.
The percentage of viable stem cells is maintained at 89% ± 10%, and to ensure consistent dosing, each batch is cryopreserved with an additional 10% of cells. We also assess mitochondrial activity, which reflects the cells’ energetic potential and their functional activity after administration, ensuring optimal therapeutic effectiveness.
At this stage, EmCell evaluates the functional activity of stem cells by assessing their colony-forming efficiency and proliferative capacity through in vitro cultivation methods. These results are essential for predicting the potential clinical effects of stem cell therapy.
We also assess the differentiation capacity of WJ-MSCs into the mesodermal lineage, specifically their ability to become chondrocytes, adipocytes, and osteoblasts in vitro. Additionally, we monitor cell senescence and the secretion of extracellular vesicles (exosomes), which reflect the stability and regenerative potential of our cell lines.
Before any clinical use, each stem cell preparation undergoes an extra visual inspection and viability check to ensure the highest quality. Maintaining robust cell viability is a cornerstone of our commitment to providing safe, effective, and reliable treatments.
This additional control not only aligns with cGMP standards but also guarantees that the therapeutic potential of the cells is fully preserved. Viability testing measures whether the cells are alive and evaluates their health, functionality, and integrity. EmCell stem cell products consistently achieve around 95% viable cells, maximizing the effectiveness of every treatment.
Wharton’s Jelly MSCs stand out because they combine ease of access, ethical acceptability, high biological potency, safety,
and therapeutic versatility. Their unique characteristics make them one of the most promising sources of stem cells in the
field of regenerative medicine today.
WJ-MSCs are collected from the umbilical cord after healthy full-term births or C-sections. Since this tissue is normally discarded, it provides a plentiful supply of stem cells without ethical concerns.
Unlike bone marrow or adipose-derived MSCs, which require invasive procedures, WJ-MSCs can be obtained safely and painlessly.
WJ-MSCs have a higher proliferation rate compared to adult stem cells. This means they can be expanded in the lab to produce larger numbers of cells while maintaining their safety and function.
These cells retain characteristics of early-stage cells, such as modest expression of pluripotency genes, giving them strong regenerative potential without the tumor risks associated with embryonic stem cells.
Absence of spontaneous transformation and uncontrolled differentiation of cells, which leads to tumorigenicity, like embryonic stem cells.
WJ-MSCs can develop into a wide range of cell types, including bone, cartilage, fat, and neural cells, making them suitable for many regenerative applications.
After administration, WJ-MSCs tend to survive longer and integrate better in the body than MSCs from other sources, potentially enhancing clinical outcomes.
A single treatment with Wharton’s Jelly-derived mesenchymal stem cells (WJ-MSCs) can provide a significantly higher number of cells compared to what is typically obtained from autologous sources such as adipose tissue, dental pulp, hair follicles, or stromal vascular fraction.
WJ-MSCs release beneficial molecules such as growth factors, cytokines, and extracellular vesicles that stimulate repair, reduce harmful inflammation, and support tissue regeneration.
They regulate immune responses effectively, calming overactive immunity (as in autoimmune diseases) or boosting underactive immunity when needed. Research suggests WJ-MSCs may have stronger immunomodulatory effects compared to bone marrow or fat-derived MSCs.
The therapeutic potential of mesenchymal stem cells (MSCs) for treating various diseases is significant. The
main mechanisms of their function have been widely studied and include the following:
MSCs release growth factors and signaling molecules that reduce inflammation, support healing, and protect cells.
MSCs attract the body’s own stem cells to sites of injury, enhancing tissue repair.
They can differentiate into bone, cartilage, or fat cells to replace damaged tissues.
MSCs can deliver healthy mitochondria to damaged cells, restoring energy and function in neurodegenerative and cardiovascular therapies.
MSCs help balance the immune system, preventing excessive inflammation and tissue damage.
They promote new blood vessel formation to improve oxygen and nutrient delivery.
They provide a scaffold and secrete factors that aid the survival and function of surrounding cells.
MSCs naturally migrate to areas of inflammation or injury, targeting therapy where it is needed.
View some of the most common questions about our treatments, stem cells and clinic.
No, mesenchymal stem cells (MSCs) are not known to cause cancer or tumors. Unlike embryonic stem cells, which can form teratomas (a type of tumor) in laboratory settings, adult MSCs do not have this risk. Thousands of clinical studies have shown that MSCs are safe, with no evidence of tumor formation in patients.
Your safety is our top priority, and only MSC preparations that have undergone a seven-stage quality and safety control process are used in our treatment programs.
After IV infusion, mesenchymal stem cells (MSCs) may temporarily pass through the lungs — this is called the “pulmonary first-pass effect.” However, due to their optimal size and strong homing ability, MSCs are not permanently trapped. Instead, they continue on to sites of inflammation or injury in the body while also releasing beneficial molecules in the lungs that support immune balance and healing.
MSCs from Wharton’s Jelly (the protective tissue of the umbilical cord) are considered immune-privileged, meaning they do not trigger an immune reaction. Unlike organ or hematopoietic stem cell transplants, MSCs do not require tissue matching and are regarded as safe and well-tolerated in clinical use.
No. For our treatments, we use mesenchymal stem cell (MSC) products derived from ethically donated umbilical cord tissue, collected after healthy full-term deliveries or C-sections. This source is classified as adult stem cells, even though they retain some of the beneficial qualities of earlier-stage cells, and therefore is not associated with the ethical debates surrounding embryonic stem cells. In fact, major faith-based organizations, including the Catholic Church and the Southern Baptist Convention, have publicly expressed support for the research and medical use of adult stem cells.
There is no risk of clot or embolism from intravenous stem cell infusion when proper clinical protocols are followed. Mesenchymal stem cells (MSCs) are generally within an optimal size range (≈17–19 µm), allowing them to pass safely through the pulmonary circulation without blocking blood flow. During production and prior to administration, the cells are processed, washed, and filtered to prevent aggregation, while viability and sterility tests ensure safety. Infusions are administered slowly under strict medical supervision to minimize hemodynamic stress. Serious complications such as embolism are virtually impossible when treatments adhere to established clinical standards.
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