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Risks of Stem Cell Therapy: Beware of unapproved and unproven commercially obtained stem cells 


Stem cell therapy is the new buzz word among physicians and patients alike.
In certain fields of medicine, it has become a game changer. This therapy has made significant inroads in treating chronic back pain and joint pain. Traditional medicine which relies on drugs and surgery to treat chronic pain has been notoriously poor in consistently providing relief. This has led to the need for better alternatives and currently, stem cells seem to have the potential.

The assurance of pain relief through stem cell therapy resulted in the mushrooming for stem cell clinics in America. But this enormous growth came with a cost, causing alarm, as many of these clinics’ primary motivation is profit and not patient care. This has unfortunately resulted in complications. In this blog, I will be discussing all the stem cell complications which have been reported in the medical literature and the media.

It is important to understand that all the risks of stem cell therapy listed below are because of the use of commercially available stem cells. These commercially available stem cells include bone marrow, adipose, umbilical cord, and amniotic tissue stem cells. There are other kinds of stem cells like expanded/cultured stem cells, embryonic/fetal stem cells and induced pluripotent stem cells.

It is mandatory to use FDA approved stem cells for stem cell therapy. There are a few deceitful providers who offer stem cells products that are neither proven nor approved. We must be careful about the potential complications involved in this procedure and check what is being provided to us in the name of treatments.

The reason for this list of complications from stem cell therapy is to find out the cause and also to tell you how to avoid the risks when you need stem cell therapy.


Three women in Florida became blind after stem cells were injected in the eyes. These patients were having macular degeneration of the eye which causes progressive blindness. Severe eye damage from stem cell therapy resulted in immediate blindness. There was an article published in the prestigious medical journal, “The New England Journal of Medicine” regarding these cases. The authors concluded that the damage to the eyes was from an enzyme used along with the stem cells. The stem cells that were used were Fat stem cells which are not approved by the FDA. Additionally, through personal communication from one of the authors of this article, I found out that the procedure was not performed by an ophthalmologist [physician specializing in the eye]. It was done by a physician assistant who is not a physician. The FDA has sought a permanent injunction to stop this clinic to stop treating patients.



CNN first broke the story about 12 patients from different parts of the country who were admitted in the hospital for severe infections after getting stem cell therapy. The FDA reported that all these cases were from the injection of umbilical cord stem cells which were contaminated. The FDA sent a warning letter to the companies which later recalled these tainted products from the market. Umbilical cord stem cells are not approved by the FDA. Additionally, the route of administration of the stem cells was also not approved by the FDA. The center of disease control [CDC] is now recommending “all” patients who received this product to get tested for HIV and other viruses.


  1. DEATH

Two patients died when a physician used stem cell therapy to “cure” their illness. The first patient was suffering from a stroke. This doctor who was a cardiologist [heart specialist] injected stem cells into the blood vessel which supplies the brain. That is like an electrician working as a plumber. This procedure clogged the blood vessel resulting in severe brain damage and death. The second patient was suffering from a lung problem. In this patient, the doctor injected stem cells in a large blood vessel. Unfortunately, the patient died. The FDA subsequently send a warning letter to the clinic. Additionally, the state medical board revoked his license.

CNN reported one patient who died on the same day of stem cell treatment from a pulmonary embolism. This was presumed to be caused by stem cells.

Reuters published a news article which described a patient who had a minor stroke. He was treated with stem cells which were injected into his spinal cord and buttocks. The patient was brain dead the next day and died a month later. No other information was available regarding the kind of stem cells used.

Another patient had bleeding complications after liposuction procedure which was done to extract fat stem cells. She was on aspirin which promotes bleeding.  These cells were injected into her veins to treat Alzheimer’s. She died on the same day as the procedure.



The New England Journal of Medicine reported a case of a patient who developed a spinal tumor when stem cells were injected in the spine. This patient was suffering from stroke complications. He received multiple stem cell treatments in different countries including China, Argentina, and Mexico. Among the different kinds of stem cells, he was given embryonic stem cells which are known to cause tumors. The spinal tumor caused the patient to get paralyzed and have urinary accidents. Radiation treatment was used to improve his symptoms.

When a lady had fat stem cells injected around the eye for a cosmetic procedure, she developed bone tumors in her eye which had to be eventually surgically removed. The fat stem cells were mixed with a filler which had calcium hydroxylapatite which is known to stimulate stem cells to create bone.



Spine Journal reported a case in which a 64-year-old patient who was suffering from chronic back pain received stem cell therapy in the spine. The patient subsequently developed a severe infection which caused disc rupture and paralysis. He had to undergo emergency surgery to treat his symptoms and later a second fusion surgery was required to stabilize his spine.



An extensive review of complications of stem cell therapy was published. One case of severe neurologic injury [severe demyelinating encephalomyelitis] was reported when a patient was injected umbilical and fat stem cells in his veins and in the spinal fluid.

In another case, a patient with kidney failure was complaining of numbness in multiple areas of her body. To treat this condition, fat stem cells taken from another person were injected into her veins. Unfortunately, this worsened her neurologic condition such that couldn’t walk and became wheelchair bound.



Three cases of pulmonary embolism [blood clots in lung] and lung injury were reported when fat stem cells were injected in the veins to treat neck pain and knee pain.

CNN reported one patient who died on the same day of stem cell treatment from a pulmonary embolism. This was presumed to be caused by stem cells.


When these complications were analyzed, the common reasons for these catastrophes are

  1. The procedures were performed by poorly trained physicians. In some cases, the procedure was done by non-physicians like physician assistants.
  2. Most of the complications occurred when stem cells which are not approved by the FDA were used.
  3. Most of the complications were as a result of treating conditions with no clinical proof of safety.
  4. The route of administration of stem cells in these cases is not approved by the FDA.


Stem cells have great potential to treat patients. Scott Gottlieb, the FDA commissioner says, “adult stem cells can generate replacements for cells that are lost to injury or disease. This is no longer the stuff of science fiction”.

Studies are showing that when properly performed, Stem Cells have an immense potential to treat pain and joint pain. However, stem cell therapy must be done in the right clinics.

To get the appropriate stem cell therapy for best results and with minimal complications, look for the following.

  1. The physician performing the procedure should be well trained in the area that is being treated. Don’t expect a plumber to treat electric problems.
  2. The physician should be trained and certified in stem cell therapy
  3. Do not let a non-physician like a nurse practitioner or physician assistant perform the procedure.
  4. Make sure the clinic used only FDA allowed stem cells
  5. Make sure the clinic uses only FDA allowed routes of administration of the stem cells
  6. Ask the clinic for published studies regarding the efficacy of the stem cell treatment for your condition

Ask the clinic for published studies regarding the safety of the stem cell treatment for your condition


For further details about finding the right stem cell clinic, read this blog.


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Dr. Sairam Atluri is a pioneer of stem cell therapy in the Cincinnati area. He is one of the very few in the country performing intra-discal and subchondral injections to treat back pain and joint pain. He gives national talks and teaches other physicians about stem cell therapy. He is also a co-editor of one of the largest textbooks about regenerative medicine. Dr. Atluri is part of the team which wrote the ASIPP guidelines for stem cells to treat back pain. He is one of the few in the area to be certified in Regenerative Medicine by American Society of Interventional Pain Physicians [ASIPP].

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    Stem Cell Therapy for Back Pain and Knee Pain. All you need to know!!

    […] severe complications like blindness, serious infections, tumors, and […]

    October 5, 2019 at 12:43 pm

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