What Is Stem Cell Therapy?
During stem cell therapy, usually your own stem cells will be removed from your bone marrow, blood or another location. They’ll then be concentrated and injected into the area of your body that requires treatment. The FDA has different rules for stem cells derived from different tissues depending on how much they’re manipulated or processed before treatment.
Some treatment involves using stem cells taken from a developing embryo or the placenta (although this is usually for experimental purposes only). Although these stem cells can specialize into any cell type and have more potential uses, there are some ethical concerns about where they’re sourced from.
Stem cell therapy can be used in traditional medicine to treat blood cancers like leukemia, while regenerative stem cell therapy focuses more on using stem cells to boost tissue healing and repair.
How Stem Cell Therapy Works
Stem cell therapy helps to address the body's declining ability to repair itself.
As we age, our stem cell populations shrink and lose their ability to produce the chemical messengers that are key for tissue repair and controlling inflammation (El Assaad et al., 2024). This can make it harder for the body to replace aging cells and repair damaged tissue.
Stem cell therapy works in two ways. Firstly, by providing a population of cells that can specialize into other cell types and directly replace damaged cells. Secondly, by boosting production of the chemical messengers that control inflammation and stimulate tissue growth and repair.
Tissue healing is complex, but stem cells help regulate inflammation, acting to both increase and limit inflammation in different scenarios (Jin et al., 2023). This can be helpful for a variety of health conditions, including wound healing, bone/soft tissue repair and even certain neurological diseases.
Who Stem Cell Therapy Helps
Stem cell therapy helps people with degenerative health conditions in particular, although it can be useful for anyone whose body has a declining capacity for repair.
Conventional medical treatments for degenerative conditions mainly focus on symptom management. For example, taking pain medication or having surgery to manage structural damage caused by arthritis.
While these treatments are an effective way to support people with degenerative conditions, regenerative stem cell therapy is another treatment option. Rather than temporarily alleviating the symptoms of a condition, stem cell therapy aims to improve the body’s ability to heal and repair the affected tissue.
How effective stem cell therapy is will be influenced by your underlying health, especially where you’re being treated with your own stem cells (Efimenko et al., 2015). Chronic inflammation from poor diet, sleep deprivation, or metabolic dysfunction undermines tissue repair even when stem cells are delivered directly to the target area (Chen et al., 2025; Moradi et al., 2025).
Smoking, alcohol and other toxins can also make stem cells less effective and impact how successful treatment is (Pavlovic et al., 2025).
Common Uses
Stem cell therapy is most commonly used to treat disorders of the blood and/or the immune system, including certain cancers. These uses are approved by the FDA.
While stem cell therapy isn’t FDA-approved for other health conditions, it is used experimentally or “off label” for other conditions, including:
Musculoskeletal conditions
Wound healing
Certain types of blindness
Stem cell therapy is being trialed for other uses too, such as:
Treating neurological conditions like Alzheimer’s disease, strokes or Parkinson’s
Repairing heart damage after a heart attack
Supporting people with type 1 diabetes who need insulin
There is a varying amount of evidence around how effective stem cell therapy is for treating these different conditions.
What the Evidence Supports
Outside of the FDA-approved uses, there’s the largest amount of evidence around regenerative stem therapy for musculoskeletal problems, particularly osteoarthritis.
A 2018 systematic review investigated the use of mesenchymal stem cells (adult stem cells that can turn into bone, cartilage and fat cells) for treating osteoarthritis. After assessing data from 28 studies, the review found that intra-articular mesenchymal stem cell (MSC) therapy is safe, with positive osteoarthritis outcomes in 584 patients (McIntyre et al., 2018).
Another review article found that MSC therapy significantly improves clinical outcomes in knee osteoarthritis based on data from six randomized controlled trials (RCTs) (Rahmadian et al., 2025).
RCTs investigating stem cell therapy to treat tendon issues have also demonstrated promising results, particularly with reducing tendon re-tear rates and pain in rotator cuff injuries (Mirghaderi et al., 2022). However, larger trials are needed to confirm these findings.
A meta-analysis including data from 524 participants also found that hematopoietic (stem cells that can specialize into any blood cell) stem cell therapy has potential applications for treating people with type 1 diabetes. After stem cell therapy, 58.9% of patients no longer needed to take insulin treatment to manage their blood sugar levels (El-Badawy & El-Badri, 2016). Stem cells helped reset the immune systems of people with insulin, providing temporary remission from type 1 diabetes.
Experimental data from 79 RCTs found that stem cell therapy can help repair heart tissue damage after a heart attack (Lee et al., 2024).
Stem cell treatment improved participants’ left ventricular ejection fraction (how much oxygen-rich blood leaves the heart) when given alongside standard treatment. This improvement was modestly larger at 6, 12, 24, and 36 months in the treatment group compared to the placebo group, who just received standard treatment to open the heart’s narrowed blood vessels (Lee et al., 2024).
Where the Evidence Is Limited
While a systematic review of 28 studies did find that stem cell therapy can improve chronic ulcer closure, the included studies were small and of low to moderate quality (Raghuram et al., 2020).
Results from early-stage trials investigating stem cell therapy for retinal degeneration suggest it could be an effective treatment (Sharma & Jaganathan, 2021). However, there’s a lack of consistency with administration, where stem cells are sourced and the long-term consequences.
Pre-clinical and early clinical trials have demonstrated some potential for treating neurological conditions. However, similarly to other therapy areas, there’s a lack of consistency and limited data (Darehbagh et al., 2024).
Safety and Regulation
Although stem cell therapy is only FDA-approved for treating blood and immune disorders (such as blood cancers, immunodeficiencies and certain types of anemia), all stem cells are regulated by the FDA.
The FDA has strict guidance around handling stem cells and donor testing to avoid the spread of infectious diseases, with more rigid requirements for stem cells coming from other donors.
Where providers offer non-FDA-approved products with unproven claims, they are liable to legal action.
The FDA is strict about stem cell therapy because we don’t yet have enough data from clinical trials to say that therapy is both safe and effective for treating unlicensed health conditions.
Stem cell therapy comes with a variety of risks, and unregulated products may have even more risks, including:
Bacterial or fungal infections
Injection site reactions
Unwanted inflammatory or immune response
Tumor formation
Transmission of blood-borne viruses
If you’re interested in experimental stem cell therapies, it’s always important to speak to a licensed healthcare professional.
Joining a clinical trial is one way to receive stem cell therapy in a setting where you’re well monitored.
There tend to be fewer risks associated with using your own stem cells rather than donor cells.
The Experience
The process varies depending on the type of stem cell therapy and where you source the cells from, but we’ll focus on treatment using your own stem cells.
You’ll start with a detailed medical history and discuss your treatment goals. Before therapy, you’ll often be advised to avoid anti-inflammatory medications, smoking and drinking alcohol.
At the hospital or treatment provider, stem cells are extracted from your bone marrow under local anesthetic or from your fat via liposuction. This process will take about an hour.
Your sample will then be processed to concentrate the stem cells and injected under ultrasound guidance into the treatment area (which takes around 20-60 minutes). Often, the area is numbed with local anesthetic first.
Most people describe the process as quick and not overly painful. After treatment, you may notice some soreness, swelling, tiredness or flu-like symptoms in the first few days. Resting for the first 48 hours will help, followed by light activities.
The Future of Stem Cell Therapy
For stem cell therapy to become more widely used, researchers and clinicians need to find a safe and effective way to provide standardized treatment.
As treatment becomes more common, it will be more and more important to have strong ethical guidance in place.
Gene editing technologies may also play a role in future stem cell therapy. This technology could be used to improve stem cell functioning and create personalized treatments (Marei, 2025).
Takeaway
Stem cell therapy uses cells with the capacity to grow and specialize into new cells as a way to repair damaged tissue and support healing. It’s FDA-approved for treating certain blood and immune cell conditions, but is also used “off-label” for more experimental purposes like treating arthritis or to heal wounds.
While there’s emerging evidence that stem cells may help with a variety of health conditions, we need more high-quality evidence before they can be licensed for other purposes. Stem cell therapy does come with some serious potential risks, so it’s important that you only seek treatment from a licensed healthcare professional that makes realistic claims.
