I have received numerous questions and phone calls asking about the efficacy of stem cell therapy on multiple sclerosis (MS). In this post, I will present the latest research on stem cell therapy and MS.
To begin, most clinics use one of three types/sources of stem cells for treatment of MS– bone marrow, adipose, or umbilical cord. Importantly, outside of a clinical trial, no clinics in the United States can culture or expand their stem cell product. In other words, the stem cells that a clinician removes from your bone marrow, or your fat, or receives from the umbilical cord product cannot be multiplied. This information is vital to know, because every clinical trial of which I am aware that has always used a cultured/expanded stem cell product. By doing this, the investigators are able to achieve MUCH higher numbers of stem cells than any clinic can obtain and use to treat. Therefore, one must take this into account when trying to interpret any study using stem cells as a therapeutic modality for MS. Said another way, you will receive, numerically, much less stem cells than the patients in the clinical trials received and thus, your results may be very different.
The most recent study published in 2018 (Meng M, Liu Y, Wang W, et al. Umbilical cord mesenchymal stem cell transplantation in the treatment of multiple sclerosis. Am J Transl Res. 2018;10(1):212-223. Published 2018 Jan 15.) reported the effects of umbilical cord stem cell therapy on MS. Unfortunately, only three patients were studied.
Patient 1 and 2 received seven injections over a 21-month period. Patient 3 only received placebo. The researchers followed the two patients for 5 and 8 years, respectively.
At the end of the study, the researchers reported their findings. They found that, “After cell treatment, the symptoms involved in unstable walking lessened, mental state, appetite, coordination ability and balance force of patient 1 were remarkably improved. The symptoms including numbness of the right limbs, constipation of patient 2 were mitigated. At the same time, mental status and memory of patient 2 were also improved, indicating the patient’s condition was stable. However, the symptoms and vital signs of patient in control group (patient taking placebo) were not improved but aggravated.”
The patients were also evaluated by using the Expanded Disability Status Scale (EDSS) which quantifies the disability of patients with MS. The researchers found that the EDSS score in patient 1 decrease/improved over the trial period while the score for patient 2 had remained stable. The EDSS score for patient 3 increased/worsened.
Last, the researchers compared pre-clinical MRIs with post-therapy MRIs in each patient. They wrote, “After patient 1 received seven times of treatments, lesions on the right side of the cerebral ventricle became pale and tended to disappear through MRI examination. In addition, the lesions on the left side were remarkably reduced and the ranges of the frontal and parietal lobes and semi-oval area were reduced. The lesion on the cervical spinal cord also became lighter. After patient 2 received four times of treatments, MRI results revealed that the high signal intensity was reduced at the site next to the left ventricle and basal ganglia. The MRI results from the patient in control, high signal intensity was visible in the white matter lateral to the bilateral ventricles and semi-oval area. Multiple nodular lesions were observed in the corona radiata and the site next to the lateral ventricles.”
In summary, the authors conclude, “Our findings confirm that umbilical mesenchymal stem cells (UCMSCs)have functions of immune regulation and nerve protection, indicating the feasibility of UCMSC transplantation for multiple sclerosis. However, because of the low number of cases in the present study, our results need to be validated in large clinical trials in the future.”
In a study published in, Multiple Sclerosis, patients underwent an autologous (from the patient themselves) hematopoietic stem cell transplantation (aHSCT) to evaluate its effects on fatigue in MS. An aHSCT is very different from what you will receive in a standard stem cell clinic. These types of transplantations are performed in hospitals and within clinical trials. Thus, their results may be very different from what a patient might receive from the routine stem cell injections found in regenerative therapy clinics in the US.
In the study, 23 patients underwent aHSCT and were clinically followed every 6 months for 36 months. At the conclusion of the trial, the researchers found that “patients had significantly less fatigue on average after aHSCT.”
The median FIS score decreased 36%, from 36 to 23 ( p = 0.001), and four patients had 100% reduction. Improvement in FIS correlated with lower age and Expanded Disability Status Scale at baseline, as well as increased independence as evidenced by a return to gainful employment and even driving.
Patients had significantly less fatigue on average after aHSCT. This may serve to better understand the contribution of ongoing CNS inflammation to fatigue peculiar to MS.( Autologous hematopoietic stem cell transplantation improves fatigue in multiple sclerosis. Bose G1, Atkins HL2, Bowman M3, Freedman MS2. Mult Scler. 2018 Sep 25:1352458518802544. doi: 10.1177/1352458518802544. [Epub ahead of print])
The final study that we will look at was published in 2007. In this study, researchers enrolled ten patients who were injected intrathecally (into the spinal canal) with culture expanded (multiplied in laboratory) stem cells. After one year, the patients EDSS were assessed and repeat MRIs were obtained. Based on the EDSS, one patient showed improvement, four patients showed no change, and five patients worsened. The MRI results showed no difference in 7 patients, extra plaques in two patients and decreased plaques in one patient.
They concluded that this type of treatment was possible, but stated that more studies are needed to draw a conclusion as to the efficacy of such treatment. (Does mesenchymal stem cell therapy help multiple sclerosis patients? Report of a pilot study.Mohyeddin Bonab M1, Yazdanbakhsh S, Lotfi J, Alimoghaddom K, Talebian F, Hooshmand F, Ghavamzadeh A, Nikbin B. Iran J Immunol. 2007 Mar;4(1):50-7.)
Bottom line? There is very little data supporting stem cell therapy as currently received in most clinics of the US. At the same time, there doesn’t appear to be any downside to stem cell therapy as far as adverse effects are concerned. As more and more studies are published, hopefully, we will have a better idea as to the efficacy of stem cell therapy for patients suffering from MS.