Are Stem Cell Therapies Safe?

Check out this answer from Consensus:

Based on the current literature, stem cell therapies appear to be generally safe across various applications, including orthopedics, chronic liver disease, and diabetes mellitus. However, continuous monitoring and rigorous reporting of adverse events are essential to further define the safety profiles of these therapies. Collaborative efforts among regulators, researchers, and clinicians are crucial to ensure the safe and effective implementation of stem cell therapies in clinical practice.

Stem cell therapies have emerged as a promising treatment for a variety of conditions, ranging from orthopedic issues to chronic diseases like diabetes and liver disease. However, the safety of these therapies remains a critical concern. This article aims to review the current literature on the safety of stem cell therapies, focusing on different types of stem cells and their applications.

Safety in Orthopedic Applications

Stem cell treatments in orthopedics, particularly for joint pathology, have shown promise due to their ability to modulate various tissue processes simultaneously. A systematic review of intra-articular treatments with culture-expanded stem cells in humans found that these therapies appear to be safe. The review analyzed 844 procedures with a mean follow-up of 21 months and reported only a few serious adverse events (SAEs), such as infections and pulmonary embolism, which were resolved with appropriate medical interventions1.

Safety in Chronic Liver Disease

Stem cell therapy is also being explored as a treatment for chronic liver disease (CLD). A meta-analysis of randomized controlled trials (RCTs) indicated that stem cell therapy is associated with improved survival and liver function. Importantly, no serious adverse events were reported in the majority of the included trials, suggesting that stem cell therapy is a safe option for CLD patients3.

Safety in Diabetes Mellitus

The safety of stem cell therapy for diabetes mellitus (DM) has been evaluated in several clinical trials. A meta-analysis of these trials found that adverse effects were observed in only 21.72% of both type 1 and type 2 DM patients, with no reported mortality. The study concluded that stem cell transplantation is a safe and effective treatment for selected patients with DM5 6.

General Safety of Mesenchymal Stromal Cells

Mesenchymal stromal cells (MSCs) have been widely used in various clinical contexts. A systematic review and meta-analysis of clinical trials found that MSC therapy appears to be safe, with no significant association between MSCs and acute infusional toxicity, organ system complications, infection, death, or malignancy. However, a transient fever was a common side effect4 7.

Regulatory and Ethical Considerations

The rapid development of stem cell therapies presents challenges for regulators, as traditional safety assessment criteria may not be suitable for cell-based therapies. It is essential for regulators, pharmaceutical providers, and safety scientists to collaborate in framing new safety guidelines based on “acceptable risk” to ensure patient safety without stifling innovation2 8. Ethical concerns, particularly regarding human embryonic stem cells (hESCs) and induced pluripotent stem cells (iPSCs), also need to be addressed to facilitate the clinical translation of these therapies9.

Are Stem Cell Therapies Safe?

Philippa Harding has answered Likely

An expert from University College London in Cell Biology, Developmental Biology, Stem Cells

Yes – Many clinically approved stem cell therapies exist, which are effective at treating diseases, such as blood (hematopoietic) stem cell therapies to treat bone marrow cancer. However, it is important to only use therapies that have been approved by government regulatory bodies, or are part of approved clinical trials to ensure they are safe and effective. Therapies currently undergoing clinical trials can be checked on government registries.

Are Stem Cell Therapies Safe?

Vik Reebye has answered Likely

An expert from Imperial College London in Oncology

If this is in reference to traditional bone marrow transplant- yes this is a safe option commonly used for blood borne diseases. 

For inducible stem cells, it is too early to label an experimental concept as safe. Science progresses at a rapid pace. With any hurdles that we come across during the development of these new therapies, an alternative pathway is found. This is the beauty of science. Many of these have been found which is progressing inducible stem cell therapy much closer to a safe and viable treatment option.

Are Stem Cell Therapies Safe?

Michael Telias has answered Likely

An expert from University of California, Berkeley in Neuroscience, Stem Cells, Vision Sciences

The question should be which stem cell therapies are safe.

Transplant of adult hematopoietic stem cells (bone-marrow) into patients suffering from specific types of cancer and other diseases have been shown to be both safe and effective.

Therapies involving induced pluripotent stem cells or embryonic stem cells are still only in the experimental phase, and we will know if they are safe and effective in the near future. In the meantime, sadly, many crooks have started offering all kinds of “stem cell therapies” that could be very dangerous and lead to the development of tumors and other problems.

The FDA, the CDC and the NIH regularly release information regarding this, and the public should be advised simply to trust these agencies and follow their guidelines.

Are Stem Cell Therapies Safe?

Andre van Wijnen has answered Likely

An expert from Mayo Clinic in Stem Cells, Cell Biology, Molecular Biology, Musculoskeletal Science, Orthopedics

The question “Are stem cell therapies safe?” is as imprecise as the question “Is cancer deadly?”

To assess whether these cells are safe requires first definition of what type of stem cells are the focus and what type of regenerative therapy is intended. There are many different cancer types and disease severities, and there many distinct stem cell types and differences in therapeutic potential. The proper generic phrasing would be of the logical shape: “Is the use of stem cell type A safe for stem cell-based regenerative strategies to treat clinical disorder B”. There are a near-infinite number of answers to this question, because there are many types and definitions for stem cells (“A”), as well as an even larger number of clinical disorders in regenerative medicine (“B”) that could potentially be treated by some type of stem cell therapy. There are many hundreds of published papers on this topic. The general consensus of the majority of these papers is that any stem cell therapy has major potential for tissue regeneration and patient care. Because many stem cell types are immune-privileged, have immune-suppressive potential and/or are non-tumorigenic, there is ample evidence for their safety in many different biological scenarios. The more germane question is whether any stem cell therapy is effective, and the answers to the latter question are far more uncertain depending on the biomedical context. 

Are Stem Cell Therapies Safe?

Karl Willert has answered Near Certain

An expert from University of California, San Diego in Stem Cells, Developmental Biology, Cell Biology

Absolutely. Having said that, this only applies to stem cell treatments that have been properly vetted and, most importantly, have gone through clinical trials and have received FDA approval. To my knowledge, the only currently FDA approved stem cell therapy is the bone marrow transplant. Other stem cell treatments are currently at varying phases of clinical trials, and only treatments that are deemed safe (assessed in Phase 1) and efficacious (assessed in Phase 2-3) will make it through the entire process.

There have been many examples of stem cell treatments that have not gone through this process. Although there may be anecdotal evidence that some of these treatments are safe and efficacious, they have yet to receive FDA approval, and no one in the field of regenerative medicine will endorse them as either safe or efficacious until that process is complete. Stem cell clinics have sprung up across the country and the world, and some patients, desperate for any type of treatment for their conditions, have traveled abroad. This is a terrible idea and I can’t stress enough how wrought with danger this may be. At best, such treatments will do no harm (aside from emptying their wallet), and at worst, it could make their condition considerably worse.

Are Stem Cell Therapies Safe?

Abigail Isaacson has answered Likely

An expert from King’s College London in Developmental Biology

Clinically approved stem cell therapies are safe. Haematopoietic stem cell transplantation (HSCT) has long been a clinically approved stem cell therapy for certain blood cancers and has low risk of adverse effects. It can be performed using a person’s own bone marrow and this ensures there is no risk of rejection. A number of safety concerns still need to be addressed with stem cell therapies that are in the process of being developed however, which generally present themselves after transplantation. These include possible tumour formation, adverse immune responses, and differentiation of the transplanted cells into unwanted cells. The extent of these risk factors largely depends on the stem cell source, for instance, somatic (adult) stem cells are more likely to form tumours after transplantation than embryonic stem cells.