[Column] Stem Cell Procedures vs. Stem Cell Therapies: What's the Difference?

I try searching for “stem cells” on an internet portal site. Dozens of combinations of words featuring “stem cells”—such as stem cell therapy, stem cell treatment, stem cell procedures, stem cell breast augmentation, and stem cell fat grafting—are flooding the media. Unless you are a medical professional or an official with the Ministry of Food and Drug Safety, it seems virtually impossible to discern the truth behind stem cell-related information.

In my previous column, I mentioned that since culturing stem cells outside the body may alter their biological characteristics, the Ministry of Food and Drug Safety classifies them as “prescription drugs” and regulates them accordingly. So, what is the reality of stem cell procedures that involve only simple isolation, without culturing?

In fact, since cells obtained through simple isolation contain many non-stem cells in addition to stem cells, the term “cell therapy” might be more appropriate than “stem cell therapy”; however, to aid the reader’s understanding, I will use the term “stem cell therapy.”

Stem Cell Treatments: Appropriate
for “Minor Localized Conditions” As the therapeutic effects of stem cells have been proven through numerous studies, many medical institutions in Korea have increasingly begun using stem cells—simply isolated from patients’ bone marrow, blood, or adipose tissue—for treatment. Under the Medical Service Act, this procedure constitutes a “medical act” and may be performed at the physician’s discretion.

Stem cell therapy can be expected to be effective for minor localized conditions. However, since the number of mesenchymal stem cells—which are effective for treatment—is extremely small in simply isolated cells, it is difficult to expect safety and therapeutic efficacy for intractable diseases or conditions requiring systemic administration. This is an area that should be addressed by specialized pharmaceuticals (stem cell therapies) in which mesenchymal stem cells are selectively isolated and cultured.

Therefore, patients considering stem cell procedures should receive an accurate diagnosis of the type and severity of their condition and carefully select a medical institution after assessing its suitability. The most important criterion for judging a medical institution’s suitability is “safety.”

Stem Cell Procedures: A Medical Facility’s Cell Processing Capabilities Are Key
to Safety I recently treated a patient who came to my clinic complaining of knee pain. The patient reported having undergone a stem cell procedure at another medical facility, but based solely on the patient’s description, I could not determine what type of stem cells had been used. It was clear, however, that a stem cell therapy product—a specialized pharmaceutical—had not been used. The examination revealed localized swelling and heat in the knee itself, suggesting the possibility of an infection rather than simple inflammation. It appeared highly likely that contaminated cells—resulting from contamination during the simple isolation and processing—had been injected as is.

The growing popularity of stem cell treatments is a welcome development. However, as illustrated by the case of the patient who visited our clinic, the situation is quite different if medical institutions handling stem cells cannot guarantee patient safety. The most important indicators for assessing the safety of a medical institution are the proficiency of the personnel handling the stem cells and the quality of the cell processing facilities.

In fact, when I established this hospital, keeping the importance of cell processing facilities in mind, I partnered with PamiCell Co., Ltd.—the developer of the world’s first stem cell therapy—to build an iGMP facility that meets the standards for specialized pharmaceutical manufacturing facilities set by the Ministry of Food and Drug Safety. We operate this facility with skilled researchers handling the cells. The problem is that, among the medical institutions currently performing stem cell procedures, only a handful possess such a verified system for cell processing.

Accordingly, the government is actively reviewing the “Bill on the Support and Management of Advanced Regenerative Medicine” as legislation to encourage stem cell procedures as a medical practice and to manage them systematically. For this bill to be effective and establish a stable system, ensuring “safety” at each medical institution will be the biggest challenge. We hope that these changes will serve as a catalyst to improve the quality of stem cell treatments used in medical institutions and that the stem cell medical industry will flourish through the government’s thorough oversight and supervision.