In this multi-part series, the previous article explained about the safe processing of cord tissue stem cells in the storage facility using various safety measures under sterile lab conditions. In this fourth part, Mr. Ramesh, Product Manager – Cord Tissue at LifeCell explains the routine tests and quality checks involved in preserving the stem cells at the cryopreservation chambers.
There are few challenges observed in the processing and proliferation of cord tissue due to its sticky nature. During the culture of mesenchymal stem cells from cord tissue, the sample is divided in to multiple parts and used for cryopreservation in Chennai and Gurgaon labs, quarantine tests and culture growth.
If the culture shows contamination, no growth or differentiation, the sample kept for quarantine tests will be retested, processed and cultured again. There are various factors that cause the above conditions; however their occurrences are very rare. Our well trained technical executives work on the following processes to try and retrieve the best batch of stem cells that are viable, effective and free of contamination from the available sample:
To Treat Contamination
If the culture shows infection/contamination, the sample stored for quarantine testing will be used to find out the microbial strain and then the culture will be decontaminated using antibiotics. Only optimal amount of antibiotics will be used in order to maintain the viability of the stem cells. If the infection is severe, the sample will be rejected upon parents’ consent. However, the chance of contamination is very slim.
To Handle ‘No Growth’ Condition
Only after 30-45 days, it is possible to spot the ‘no growth’ condition in stem cell culture medium due to the changes in the nature of stem cells. This is a rare scenario observed in the stem cell processing. Upon parents’ consent, the cultured sample will be rejected; however, the cord tissue and cord blood sample cryopreserved will be retained for future use as it can produce desired amount of stem cells with advance culture techniques during the time of transplant.
To Treat Matured Cells
In rare cases, if a single stem cell in the culture media picks up any external signal due to abnormal conditions, they might differentiate into other type of cells instead of the desired mesenchymal stem cells. This may lead to the rejection of that particular colony of stem cells; however, the cord tissue stem cells will be cultured again using the part stored for quarantine tests.
Quality Analysis of Samples
After the stem cells are harvested from the culture medium, they are measured to check for the desired amount of cell growth followed by quality check that includes cell viability and sterility (free from contamination). When asked about the quality check and information about preservation certificate, Ms. Girija Kumari, Team Leader – Technical Queries at LifeCell said, “We maintain 3-level quality approvals to confirm the safe storage of samplesnin our lab”. If the stem cells satisfy quality testing, it will be preserved in the cryopreservation chamber.
“Every cord tissue sample that undergoes cryopreservation must be approved by the LifeCell’s cord tissue product manager in the storage facility. The quality assurance team will perform data verification provided by the processing team to ensure viability, sterility, cell count and proliferation of the sample, followed by the approval from lab director to release the preservation certificate to parents,” she added. At LifeCell, quality checks are performed at every stage based on the US FDA guidelines to provide multiple levels of safety and assurance for your baby’s stem cells.
The preservation certificate for cord blood, maternal blood and cord tissue will be sent to the parents as soon as the complete preservation process is over. The preservation certificate for cord tissue contains the following: