This past month, the FDA approved a study that will investigate the value of stem cell therapy in autism. (1)

This is big news. Especially since stem cell tourism is on the rise.

Anyone who purchases umbilical cord blood from this particular clinic could be injecting far more cellular debris than stem cells into their child.

According to Dr. Michael Chez, who leads the study, “…many people are going to foreign countries and spending a lot of money on therapy that may not be valid.” (2)

The problem isn’t so much that stem cell therapy is bogus (we’re still figuring out what about stem cell therapy works and what doesn’t), but that it is not tightly regulated. This can lead to fraud - and has. (3)

In January, 60 Minutes reported on a stem cell clinic overseas that offers umbilical cord blood. The problem: Researchers at Duke University found that in one sample, only 100 of 20 million stem cells were still alive.

Parents of children with autism are desperate to find treatment. While stem cell therapy is being explored as a possible treatment for autism, there are still many more questions that must be answered before a cure is discovered.

This means that anyone who purchases umbilical cord blood from this particular clinic could be injecting far more cellular debris than stem cells into their child. In a child with autism, this most definitely poses a problem.

However, parents of children affected by neurological disorders like autism or cerebral palsy are eager to see their child improve. Even if it means radical therapy that is backed only by anecdotal evidence.

In China, stem cell clinics claim huge success with autism. Chief neurologist at Beijing Puhua International Hospital, Zhou JingLi, says many of their autistic patients see significant improvement within a couple of weeks after treatment. (4)

So far, both abroad and in the United States, there is little scientific, clinical data to support the claim that stem cell therapy has long-term benefits.

Stem Cell Therapy: What It Is and What It’s Good For

Stem cell therapy offers significant hope for a wide range of disorders besides autism. Many autoimmune conditions, degenerative disorders, and injuries can possibly benefit from stem cell therapy.

Stem cells can come from several different places:

  • Umbilical cord blood
  • An embryo or a fetus
  • Amniotic fluid
  • Bone marrow
  • Fat tissue
  • Dental pulp

Pulling stem cells from a patient’s own tissue poses less of a risk of rejection.

Across the globe, researchers now use stem cells in the fields of regenerative medicine and to artificially reconstruct damaged tissue.

Many stem cells have the ability to differentiate and become fully developed cells, replacing muscle or organ tissue. This means that depending on its environment, a stem cell can mature and become just about anything!

Stem cells have been used to treat a variety of inflammatory and degenerative diseases. (5) This is because stem cells:

  • Can differentiate between many types of cells like bone, fat, and muscle.
  • Have the natural ability to detect changes in the environment, like inflammation.
  • Can help to heal and restore an inflamed and damaged area in the body.

Can Stem Cell Therapy Help Children Recover from Autism?

The recently approved FDA trial of stem cell therapy in autistic patients is scheduled to end in August 2013.

This study is everything it should be: randomized, crossover, placebo-controlled, and double blind. What this means is that in the world of science, the trial meets all the criteria that qualify it as reliable.

Researchers, led by Dr. Chez, will work with 30 autistic children, ranging from two to seven years old. The children will be randomly divided into two groups of 15.

Depending on which group a child falls into, each will receive either saline solution or stem cells from his or her own banked umbilical cord blood. The trial is double blind, which means that the staff from the Blood Cord Registry, the physicians, and the parents do not know which child is receiving saline and which is receiving umbilical cord blood.

Halfway into the trial the two groups will switch, making this a crossover study. Again, neither the investigator nor the parents will know which child is receiving saline and which is receiving umbilical cord blood.

The behavior of the children will be tested along the way.

Are There Subsets in Autism?

When it comes to autism, researchers believe that there are roughly three subsets:

  1. One with immune abnormalities.
  2. Another with little or no immune abnormalities.
  3. A final group with mixed traits.

This is important to note. The study that the FDA approved in the US is looking for signs of inflammation, or “immune abnormalities.” In the body, these signs come in the form of biochemical markers.

This poses a problem because, while autism has been linked to inflammation, this may not be the only mechanism at work. (6) Truth be told, we are still piecing the puzzle together. Since only one subset of autistic children may have immune abnormalities, this could be the only group that benefits from stem cell therapy.

If the study looks like a flop because of selection criteria, this could be bad news for the future of stem cell research.

According to Paul H. Patterson, a researcher at CalTech who just published a book on the relationship between the immune system and autism: “I would have preferred to have the autism subjects be chosen for the presence of immune abnormalities, which is what this procedure may be testing…my biggest worry is that if no efficacy is found, stem cell therapy for disorders in young children in general will receive a major setback.” (7)

What To Remember Most About This Article:

The FDA recently approved a study that will investigate the value of stem cell therapy in autism.

Nonetheless, many parents of children with neurological disorders like autism or cerebral palsy are desperate for treatment and may even consider radical therapy that is only backed by anecdotal evidence. In the US and abroad, there is still little scientific data to support that stem cell therapy has long-term benefits.

Stem cell therapy is intended to treat a wide range of disorders, beyond autism; these include degenerative disorders, autoimmune conditions, and injuries.

However, the jury is still out when it comes to whether or not stem cell therapy can help children with autism. Autism is believed to have roughly three different subsets related to immune abnormalities, and there are still a number of questions that must be answered before treatment can be established.


  1. Autologous Cord Blood Stem Cells for Autism.
  2. A Adams. Stem cell trial for autism: hope vs. caution. California Institute for Regenerative Medicine. 2012 Aug 28.
  3. "60 Minutes" investigates online stem cell fraud. CBS News. 2012 Jan 6.
  4. D Cyranoski. China’s stem-cell rules go unheeded. Nature. 2012 Apr 12; 484, 149 – 150. doi:10.1038/484149a
  5. D Karussis, et al. Immunomodulation and neuroprotection with mesenchymal bone marrow stem cells (MSCs): a proposed treatment for multiple sclerosis and other neuroimmunological/neurodegenerative diseases. J. Neurol. Sci. 2008 Feb; 265 (1-2): 131–5. doi:10.1016/j.jns.2007.05.005.
  6. TC Theoharides, et al. Mast cell activation and autism. Biochimica et Biophysica Acta (BBA) - Molecular Basis of Disease. 2012 Jan;1822 (1) 34 – 41.
  7. PH Patterson. Clinical trial of stem cell therapy in autism. Infectious Behavior. 2012 Sept 03.
These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

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