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In a world of regenerative medicine that is advancing rapidly, it is important to select a good stem cell supplier. As of now, numerous clinics and centers claim to provide high-quality stem cells. However, selecting a good stem cell supplier, providing high quality stem cells is important to ensure that the patient receives the best personalized stem cells. Moreover, choosing personalized stem cells from any unauthorized centers poses a significant risk of rejection and other health issues.

Consequently, this blog seeks to provide insights on the criteria for choosing the right stem supplier, challenges and limitations associated with various stem cell sources, what questions you need to ask the stem cell suppliers, purity and viability tests, regulatory considerations, and how to choose the best stem cell supplier.

Criteria while choosing the right stem cell supplier

The potency of stem cells is confirmed through various bench to bedside experiments. However, choosing the right stem supplier is important to achieve safe, effective, and beneficial results. Therefore, we should keep certain criteria and considerations in mind before selecting the stem cell provider.

  1. Firstly, it is important to know whether those claiming to be stem cell suppliers own a lab or they are procuring personalized stem cells from somewhere else.
  2. Stem cells lab or centers should possess cGMP certificate in order to provide personalized stem cells
  3. Then the lab centers should possess advanced technologies to provide the best, safest, and high-quality personalized stem cells.
  4. Generally, choose only those labs where the production of personalized stem cells corresponds with the DCGI guidelines.
  5. Moreover, stem cells are transported in cold chain to maintain their viability. Currently, all the reputed transporters are using data logger to make sure that the cold chain was maintained throughout. This data will be helpful to understand how stem cells were transported from suppliers to the therapeutic centers.
  6. Finally, consider only those labs or centers that are authentic and give viability certificates at the time of dispatch. The authenticity of the labs is only determined by the cGMP certificates.
  7.  Before the labs or centers provide stem cells, they carry out various microbial tests like mycoplasma detection, bacteria, fungi test and endotoxin test.
  8.  In case of allogenic supplier, donors undergo physical examination, laboratory blood tests to detect presence of any infectious diseases and HLA (Human leukocyte antigen) to match the donor with the patient.

What are the different available sources of high-quality stem cells for therapeutic applications?

Stem cells are cells that have the capacity to differentiate into different types of cells in the body depending upon the need. Thus, the different available sources of high-quality stem cells for therapeutic applications are bone marrow stem cells, adipose tissue derived stem cells, mesenchymal stem cells and amniotic derived stem cells.

Bone marrow derived stem cells: These high quality stem cells are present in the bone marrow. They differentiate into specialized cells depending on the origin of the tissue.

Adipose tissue derived stem cells: Generally present in the adipose tissue or fatty region of the body. These cells are extracted from region where sufficient amount of fat is present.

Umbilical cord derived stem cells: The stem cells from umbilical cord can be extracted both from umbilical cord blood and umbilical tissue.

Mesenchymal stem cells: Usually present in the mesenchyme or connective tissue surrounding the organs and tissues and can specialize or differentiate into bone, muscle, or cartilage cells.

Amniotic fluid stem cells: These high-quality stem cells have the ability to develop into specialized cells and are present in amniotic fluid.

Limitations and challenges associated with each source including autologous and allogeneic source

The limitations and challenges that we can associate with autologous and allogeneic sources are as follows:

Limitations and challenges associated with autologous sources:

  1. Since autologous stem cells are short-lived ex-vivo, the personnel need to transplant them quickly within a short period frame which can be sometimes difficult.
  2.  The limitation of autologous stem cells is collecting sufficient number of cells that have the ability to proliferate.
  3. The demand for personalized therapy also increases the financial burden.
  4. However, the other challenge is the availability of patients’ quality cells that has the ability to regenerate according to the need.

Limitations and challenges associated with allogeneic sources:

  • Large scale manufacturing of mesenchymal stem cells to minimize batch variations.
  • The stem cells have to be tested for:
  • Firstly, possibility of undesirable immune rejection leading to graft versus host disease (GVHD).
  • Then next, higher risk of contamination, disease transmission, and immune sensitivity.
  • Finally, organ toxicity is another possibility with allogenic sources.

Why is it better to select only mesenchymal stem cells from the umbilical cord?

The stem cells isolated from the umbilical cord possess numerous advantages which makes it a choice for selection. They are:

  1. The high-quality stem cells from the umbilical cord can be collected non-invasively.
  2. Additionally, the personalized stem cells isolated from umbilical cords are Day 0 cells and are very naïve without any adulterations from environmental stressors, etc.
  3. According to the study titled “Comparison of mesenchymal stem cells from bone marrow, umbilical cord blood and umbilical tissue, it is reported that the umbilical cord-mesenchymal stem cells have greater self-renewing capacity compared to others.
  4. Generally, these high-quality stem cells have a low immune rejection rate and a lower risk of infections.
  5. Additionally, the other advantages are – the cells are non-cancerous and abundant in supply.

How one should confirm that the cells they are getting are viable?

To confirm that the cells they procure are viable, ask for the viability certificates mentioning the total live and dead cells present in the population of cells. Additionally, the certificate should be authentic and include details like cell viability, flow analysis report, and other quality control tests.

The flow analysis report uses flow cytometry to determine whether the cell population has enough fractions of stem cells or not based on the analysis of the surface markers. The quality control tests ensure that the cells are pure and of high quality.

How one should confirm that the cells assigned for clinical applications are pure?

It is important to ensure that the cells that we assign for clinical applications are pure. Therefore, to assess the purity and quality of cells, we can employ various quality control parameters.

Cell viability: It is the number of cells that are viable or healthy in a population. Generally, cell viability is measured to calculate the survivability of the cells. Finally, researchers and clinicians, use automatic cell counter to count and analyze the number of healthy cells.

Flow analysis: It involves the use of flow cytometry to determine and estimate the percentage of desired and viable high-quality stem cells. The technique basically employs the use of fluorescent markers to analyze the specific stem cells and contamination molecules if any.

Endotoxin test: If the sample of cells has gram-positive bacteria then there are high chances that the bacteria might release endotoxin. Above all, these endotoxins are capable of causing many adverse reactions. Therefore in order to ensure that the cells are pure, it is important to carry out endotoxin testing.

Fungi and Bacteria contamination testing: Contamination with microbes can occur at any stage of cell culturing, manufacturing, or transport. For this reason, in order to keep the cells free from microbial contamination, high-quality stem cells providers perform gram staining. This ensures that the cells are sterile before the final step.

How the suppliers are ensuring sterility and issues related to microbial contamination?

Suppliers employ current GMP guidelines to maintain sterility and prevent microbial contamination. Additionally, they employ aseptic processing to closely monitor the operations and facilities.

  1. They monitor temperature, pressure, airflow, and microbial contamination at the facility.
  2. All the equipment and reagents are thoroughly sanitized and sterilized.
  3. Additionally, carry out purity and quality testing on all the raw materials.
  4. The personnel employed for operations always use high-quality gloves, gowns, and shoes.
  5. Finally, they conduct microbial contamination tests at regular intervals to ensure products are free of microbes.

Why is it needed to ensure that the cells required for clinical application are fresh, without any traces of DMSO, and are metabolically active?

The cells that are meant for therapeutic use should be fresh and metabolically active so that they retain the ability to differentiate into specialized cells depending on the requirement. Additionally, it is also important that they should store stem cells at a particular temperature in order to be viable.

DMSO (dimethyl sulfoxide) use as a cryopreserving for the preservation of stem cells is harmful to the survival of the cells. Above all, its use has the ability to slow down the functional process and cause mild to severe adverse effects. Even in cases where cryopreserved cells are used, DMSO use should be completely eliminated from the culture as it is neurotoxic in nature. As a result of it, its use has been not recommended for cryopreservation.

Is there any recent development in the science of regenerative medicine?

The recent advancements in technologies in the science of regenerative medicine have led to the isolation of exosomes. Exosomes are molecules that enhance various cellular activities such as tissue reconstruction, immune system response regulation, and restoration, by transmitting them to other cells. Exosomes offer a targeted, error-prone delivery. However, with advanced technology, it is possible to isolate exosomes from different stem cells depending on the application.

Exosome vehicle based therapies are going to be possible in the future since researchers have shown an interest in utilizing exosomes to their full potential. Therapy in which exosomes are incorporated as vehicles to deliver therapeutic components is known as exosome-based therapy. However, the current exosome-based research focuses on finding and establishing diagnostic and therapeutic applications of exosomes. Hence, Exosome therapy has the potential for future treatment.

Conclusive statement

Stem cell therapy has shown enormous and immense potential in the regenerative medicine discipline. Therefore, it is important to choose high-quality stem cells from a regulated and authentic stem cell supplier.

It is important to consider the criteria before choosing a stem cell provider. Basically, it is important to keep in mind that the center should have regulatory compliance, certificates, advanced technologies, and infrastructure. They should provide safe, viable, and high-quality stem cells.

While stem cell therapy has enormous potential, a regulatory procedure to control unethical and average-quality stem cells could pave the way for future advancements.

FAQ’s

Q: What are the limitations and challenges associated with autologous sources?

The limitation of autologous stem cells is producing a sufficient number of cells that have the ability to proliferate under the manufacturing procedure. And the challenge is that the personnel need to transplant autologous stem cells quickly within a short period frame which can be sometimes difficult.

Q: What is cell viability and how can we measure cell viability?

It is the number of cells that are viable or healthy in a population. Generally, cell viability is measure of survivability of the cells. They use automatic cell counter to count and analyze the number of healthy cells.

Q: What are the limitations that we associate with allogeneic sources?

Possibility of undesirable immune rejection leading to graft versus host disease (GVHD), higher risk of contamination, disease transmission, and immune sensitivity. Additionally, organ toxicity is another possibility with an allogenic source.

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