Stem cell therapy (direct-to-consumer)
Alternate names: Adipose Derived Stem Cell Therapy, Commercial Stem Cell Therapy, Commercial Stem Cell Transplant, Commercial Stem Cell Transplantation, Mesenchymal Stem Cell Therapy, Mesenchymal Stromal Cell Therapy, Stem Cell-Based Interventions, Stem Cell Clinics, Stem Cell Tourism, Stem Cell Treatments, SCBI
Actions: General, Bone, Cardiovascular, Genitourinary, Neurological, Ocular
Background
Stem cells are cells in the body that can make copies of themselves (self-renew). They can also develop (differentiate) into more specialized cells. The body naturally uses stem cells to replace damaged and diseased tissue. There is interest in using stem cell therapy as a medicine.
The US Food and Drug Administration (FDA) has approved stem cell therapy for limited use in some people with cancer or aplastic anemia. Stem cell therapy is also being studied in some clinical trials under an "Investigational New Drug" or "IND" application. Stem cell therapy that is FDA-approved or that is being studied under an IND application helps assure that the product is safe, pure, and of appropriate strength.
But there are companies marketing stem cell therapy directly to consumers for many unapproved conditions and without an IND application. These conditions include diabetes, heart disease, Parkinson disease, and many others. There's no good scientific evidence to support these uses. Direct-to-consumer stem cell therapy is also unsafe and has been linked to many serious adverse events including death.
The US Food and Drug Administration (FDA) has approved stem cell therapy for limited use in some people with cancer or aplastic anemia. Stem cell therapy is also being studied in some clinical trials under an "Investigational New Drug" or "IND" application. Stem cell therapy that is FDA-approved or that is being studied under an IND application helps assure that the product is safe, pure, and of appropriate strength.
But there are companies marketing stem cell therapy directly to consumers for many unapproved conditions and without an IND application. These conditions include diabetes, heart disease, Parkinson disease, and many others. There's no good scientific evidence to support these uses. Direct-to-consumer stem cell therapy is also unsafe and has been linked to many serious adverse events including death.
Safety Safety definitions
When given as a shot or by IV: Direct-to-consumer or "commercial" stem cell therapy is LIKELY UNSAFE. Direct-to-consumer stem cell therapy has been linked to many serious adverse effects such as cancer, vision loss, blood infections, stroke, heart attack, and death. There is also concern that not all adverse effects that happen are reported. Avoid direct-to-consumer stem cell therapy.
Effectiveness
NatMed Pro rates effectiveness based on scientific evidence according to the following scale: Effective, Likely Effective, Possibly Effective, Possibly Ineffective, Likely Ineffective, Ineffective, and Insufficient Evidence to Rate.
Insufficient evidence Effectiveness definitions
- Chest pain (angina). Early research suggests that stem cell therapy might reduce episodes of chest pain in some people. But it might also worsen the ability of the heart to pump blood. The FDA has not approved stem cell therapy for treating chest pain.
- Back pain. It's too early to know if stem cell therapy can reduce back pain. The FDA has not approved stem cell therapy for back pain.
- Cerebral palsy. Early research shows that stem cell therapy doesn't improve movement in children with cerebral palsy.
- Heart failure and fluid build up in the body (congestive heart failure or CHF). Stem cell therapy doesn't seem to reduce re-hospitalization or improve the ability of the heart to pump blood in people with heart failure. But it might reduce the risk of death and the risk of non-fatal heart attack in people with this condition. However, the FDA has not approved stem cell therapy for heart failure.
- Diabetes. It's too early to know if stem cell therapy improves long-term blood sugar control in people with diabetes. The FDA has not approved stem cell therapy for diabetes.
- Crohn disease. Early research shows that stem cell therapy might improve symptoms and the rate of remission in people with Crohn disease. But higher quality research is needed to confirm. The FDA has not approved stem cell therapy for Crohn disease.
- Foot sores in people with diabetes. Low quality research suggests that stem cell therapy might help heal foot sores in people with diabetes. But higher quality research is needed to confirm. The FDA has not approved stem cell therapy for foot sores in people with diabetes.
- Liver disease. Early research shows that stem cell therapy might improve markers of liver injury in people with liver disease. But it's unclear if it improves liver injury based on image testing or tissue analysis. The FDA has not approved stem cell therapy for liver disease.
- Osteoarthritis. Low-quality research shows that stem cell therapy might reduce pain in people with osteoarthritis. Higher quality research is needed to confirm. The FDA has not approved stem cell therapy for osteoarthritis.
- Multiple sclerosis (MS). Stem cell therapy might slow the progression of MS in some people with severe MS that doesn't respond to usual treatment. But higher quality research is needed to confirm. The FDA has not approved stem cell therapy for multiple sclerosis.
- Heart attack. Stem cell therapy doesn't seem to reduce the risk of death, re-hospitalization, or second heart attack in people who have had a heart attack.
- Narrowing of blood vessels that causes poor blood flow to the limbs (peripheral arterial disease). Low-quality research suggests that stem cell therapy might reduce amputation and improve ulcer healing in people with this condition. But higher quality research is needed to confirm. The FDA has not approved stem cell therapy for peripheral arterial disease.
- Parkinson disease. Early research shows that stem cell therapy improves symptoms of Parkinson disease based on some scales, but not others. The FDA has not approved stem cell therapy for Parkinson disease.
- Injury to the spinal cord. Early research shows that stem cell therapy doesn't improve symptoms in people with an injury to the spinal cord. In fact, it might slow recovery in some people.
- Stroke. Early research shows that stem cell therapy improves function after a stroke based on some scales, but not others. The FDA has not approved stem cell therapy for stroke.
Dosing & administration
Direct-to-consumer stem cell therapy involves taking different types of stem cells and injecting/transplanting them into the body part that is being treated. For example, in osteoarthritis of the knee, stem cells can be injected into the knee joint.
Interactions with pharmaceuticals
It is not known if this treatment interacts with any medicines. Before using this treatment, talk with your health professional if you take any medications.
Interactions with herbs & supplements
There are no known interactions with herbs and supplements.
Interactions with foods
There are no known interactions with foods.
Action
Stem cells are cells that can develop into more specialized cells. Stem cell therapy involves using stem cells to replace damaged and diseased cells in the body. For example, in osteoarthritis, the bone and the cartilage degrade and this causes pain. It is thought that stem cells can help regrow the bone and cartilage and reduce pain in osteoarthritis.
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This monograph was last reviewed on 07/12/2023 11:00:00 and last updated on 10/07/2020 03:10:51. Monographs are reviewed and/or updated multiple times per month and at least once per year.
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Natural Medicines rates safety based on scientific evidence according to the following scale: Likely Safe, Possibly Safe, Possibly Unsafe, Likely Unsafe, Unsafe, and Insufficient Evidence to Rate. For more information about Natural Medicines’ Safety Rating System, click here.
The Natural Medicines Effectiveness Ratings are assigned for specific indications. A product might be rated "Possibly Effective" for one condition, but be rated "Likely Ineffective" for another condition, depending on the evidence. For more info click here.
