Journal of Biomedicine

Cell Medicine News
For the Benefit of Patients and Clinicians

Challenges in the Intravenous Administration of Cellular Products

Intravenous (IV) treatments are often seen as affordable options because they typically do not involve hospitals, doctors, or medicolegal liability. However, they may introduce risky experimental products into the bloodstream, often labeled as “stem cells,” which the provider claims are safe. It raises the question: why do some patients, who are concerned about the side effects of COVID-19 vaccines, consider it safe to allow unknown cellular products directly into their veins? Is it simply effective marketing?

IVs offer a convenient method for delivering chemical drugs that are not altered by the body’s biology but rather work on target tissues until they are metabolized. Before any drug is made available to the public, its safety and efficacy are established through well-defined bioavailability and bioequivalence studies.

In contrast, there are no scientifically established parameters for dosing, administration, characterization, or applicability of cellular products for specific conditions. The information surrounding these products is often determined by providers and replicated by others primarily for marketing purposes.

Cell biologics exert their effects through paracrine interactions with cytokines. They can readily change form, release proteins, or break down, leaving organic debris that may alter immune responses.

For most cellular products currently available, neither their nature nor their mode of action within the venous system is clearly defined, generally rendering them ineffective at reaching the target tissue.

IVs are used to help manage systemic disorders. However medical conditions do not have a purely systemic component. Systemic influences are typically secondary effects accompanying various other damages to organs. Damage to organs primarily highlights symptomatic disorders. In medicine, comprehending the full scope of a disorder and identifying the best approach to address it becomes the focus of experimentation. Drug molecules apply destructive principles to alleviate symptoms, opportunistic infections, neurological sensations, or the release of pro-inflammatory cytokines from distressed tissues. While these methods can provide quick relief, their effects are often limited.

On the other hand, the application of cellular therapy is not aimed at alleviating symptoms, but rather at biological interactions necessary for tissue repair. For effective repair, these cells must remain alive, divide, differentiate, or secrete paracrine materials as needed. Achieving this complex set of requirements is rarely accomplished in medical practice, particularly when mass production becomes a significant economic factor. Consequently, pharmaceutical regulations tend to focus on synthetic products derived from biologics, known as biosimilars. These can yield similar results as the original cellular products and are easier to transport, store, and safely administer in larger quantities. This focus on synthetic products may prevent biopharmaceutical companies from fully exploring the potential of cellular regenerative medicine, which is better suited to personalized formulations.

Degenerative changes vary significantly among individuals, whereas symptom suppression is generally related to neurological or inflammatory issues. This leads to widespread production of painkillers targeting these conditions. Cellular therapy, however, is highly specific to each individual, making mass production challenging. This gap in focus on cellular regenerative products presents opportunities for smaller companies to enter the market. While midsize biopharmaceutical companies work diligently to isolate cellular products and establish their applicability for specific disorders, many beauty clinics and spas, especially in tourism hotspots, have shifted from cosmetic treatments to offering “stem cell” therapies. These entities often make unscientific and misleading claims, using products they poorly understand, which can result in immune damage and infections. They frequently suppress adverse events through targeted marketing campaigns that propagate misinformation.

Patients seeking solutions must educate themselves about the application of experimental medicine to their conditions and choose providers who prioritize medical ethics and rational treatment approaches. Ultimately, a properly applied cellular product, administered in sufficient quantities close to areas of damage, can yield desirable results. While quick relief is possible in some instances, it should not be the primary goal of cellular therapy. Instead, stabilization following effective therapy often occurs over a span of up to ten months.