Caffeine is inexpensive, reasonably safe at doses of under 400 mg daily, and has plausible mechanisms by which it could slow ALS progression. However, data from pre-clinical models are contradictory and a two cohort studies showed no clear relationship between caffeine intake and ALS progression. Based on all this, we cannot endorse caffeine as anALS treatment.
Patient case reports
ALSUntangled reviews alternative and off-label treatments on behalf of people with ALS who ask about them. Here we review rituximab, a drug which specifically depletes B lymphocytes. We show a current lack of evidence for a role of these cells in ALS progression. The one patient we found who described using Rituximab for their ALS found no benefit. Given all this, and the known serious risks of rituximab, we advise against its use as an ALS treatment.
You can read it here
There are good theoretical mechanisms for carnitines, some pre-clinical evidence for
LC and ALCAR, and a single clinical trial that suggested ALCAR could slow disease progression in PALS. All three carnitines appear to be well-tolerated, generally safe, and inexpensive. We believe that there is a need for future clinical trials of carnitines in PALS to further elucidate their efficacy. Until there is further data, we cannot endorse any of these supplements as a definite way to slow ALS progression; however, oral ALCAR at 1000mg three times daily (3000 mg total daily dose) appears to be a theoretically promising supplement available for PALS whom would like to self-experiment.
Copper dysregulation may play a role in ALS progression, particularly for the form caused by SOD1 mutations. Given the complexity of this problem, simple copper supplements are unlikely to be useful to PALS with normal serum copper levels. We do not recommend using these. CuATSM, on the other hand, has more promising potential mechanisms of action, and several positive pre-clinical studies in mutant SOD1 ALS models. There are even a small number of PALS reporting benefits from it, though in our opinion the described benefits are thus far of uncertain clinical significance. At this time, the safety of repeated doses of CuATSM is unknown, as is the optimum daily dose, and it appears to be very expensive. Until trials clarify dosing and safety, as well as effectiveness in patients with and without SOD1 mutations, we do not recommend using CuATSM for ALS.
Click here to download the complete review.
Acuscope appears reasonably safe, but it is not clear that it has a mechanism of action that would be useful to PALS. One person with PLS experienced slightly slower ALSFRS-R measurements while using Acuscope than she did before starting it, but a PALS had slightly faster ALSFRS-R progression during treatment. Since the natural history of motor neuron disease progression can vary spontaneously, it is not clear that either of these slight changes in progression were related to the treatment. Given these limitations, at this time we cannot endorse the use of Acuscope to slow, stop or reverse ALS progression.
Click here to download the complete review.
At this time, there is evidence that PALS, like those with other chronic illnesses, are at increased risk for vitamin D deficiency. It is, therefore, reasonable to screen PALS for this. If vitamin D deficiency is found, it seems reasonable to supplement vitamin D according to established guidelines (31) in order to avoid medical complications of vitamin D deficiency. It is not yet clear, however, that vitamin D supplementation can slow disease progression, improve muscle strength, or reduce falls in PALS. We support further studies to answer these questions.
Now 26 months old, ALSUntangled (www.alsuntangled. org) investigates alternative and off-label treatment options in ALS using social networking tools. Our twitter and NING memberships continue to grow. To date we have published 10 investigations on 11 different alternative and off-label treatment options, collaborating with Quackwatch (www. quackwatch.org), Patients Like Me (www.patients likeme.com) and ALS Worldwide (www.alsworld wide.org). We now present our investigation of NuTech Mediworld’s ALS treatment regimen which was undertaken at the request of patients with ALS (PALS).
NuTech Mediworld is a ‘stem cell clinic’ in New Delhi, India and is run by Dr. Geeta Shroff. In an effort to obtain information about the clinic, we tried to start with the clinic website (www.nutech mediworld.net), but this site has been down for the entire three months that we have been working on this piece. We made three attempts at contacting Dr. Shroff via email at the address we found on the web (1); unfortunately, we received no responses. We performed a search of the literature using Pub Med; we could not find any articles published by Dr. Shroff. She has apparently applied for patents related to the use of human embryonic stem cells used in a variety of seemingly vague ways to treat more than 70 human diseases including motor neuron disease (2). Blogs, YouTube videos and various interviews with patients with ALS suggest that Dr. Shroff is an ‘infertility expert’, using a cell line derived from a single embryo, and that these are being injected multiple times into the spinal fluid (2). In an interview Dr. Shroff suggested that, as of 2007, she had treated “more than 300” patients and that “almost everybody” had improved (3). In that same interview, it was noted that she was not using “any immunosuppressants or anti-rejection drugs” along with her treatments (3). Beyond this, we have been unable to find any presentation of an actual ALS treatment protocol, or any detailed safety or efficacy data.
We found two PALS who received treatment at Nu tech Mediworld and were also cared for by ALSUntangled affiliated clinicians. The first was a 44-year-old male, diagnosed in early 2010. He started regular follow-ups with an ALS expert only after his trip to NuTech Mediworld in June 2010, so it is not possible to examine validated outcome measures before and after his treatment there. How- ever, he provided a discharge summary from NuTech Mediworld with Dr. Geeta Shroff listed as ‘doctor in charge’. Interestingly, this contains no record of the patient’s prior work-up; furthermore, the only neurological examination states that the patient was ‘conscious, cooperative alert, oriented with time, place’. Thus, it does not appear that any objective confirmation of his ALS diagnosis was made. No consent form was provided with the discharge summary. Some testing was reportedly performed in the clinic. This included a blood count, serum chemistry, ‘Australia Antigen’, HIV, urinalysis, B12, vitamin D level, chest X-ray, EKG, abdominal imaging, echocardiogram, and brain SPECT scan. Under ‘treatment given’ the document merely states ‘patient was given human embryonic stem cell therapy during his stay in this hospital’. His ‘condition during discharge’ was noted to be ‘satisfactory’ with decreased ‘fatigue’, ‘walking, balance better’, increased ‘UE power’. Again, there are no validated measurements documented to confirm these conclusions. The patient reported receiving injections into his back, neck, shoulders and hands. Additionally, he reported receiving ‘three different antibiotics’ for ‘Lyme disease’ under Dr. Shroff. ‘Physiotherapy as advised’ was prescribed.
The second patient was a 36-year-old female, diagnosed in May 2010 and followed by an ALS expert before and after the NuTech Mediworld treatment. A discharge summary was not available on her, but she recalled events similar to the previous patient. These included a lack of neurological examinations, unusual testing including a Lyme test, and unusual adjunctive therapy including antibiotics for Lyme disease (even though her Lyme test was negative). Clinical data appear in Figure 1. Her weight, vital capacity and ALSFRS-R scores all appeared to worsen slowly over the first few months of her disease. Following treatment at NuTech Mediworld in late September 2010, her weight and vital capacity appeared to drop precipitously. Between May and mid-September 2010, her weight was stable and predicted vital capacity changed by only 4%. Between September and mid- February 2011, her weight dropped by 32 pounds, and her predicted vital capacity dropped by 25%. Subjectively this patient felt that her bladder control was improved by her NuTech Mediworld treatment. Her treatment cost $45,000 and was not covered by insurance (4). She did not recall any side-effects.
According to the ALS Worldwide publication ‘A Patient’s Path through the Maze of Stem Cell Transplantation’, Dr. Shroff ‘has no background in stem cells, has never published anything and makes extraordinary claims to have cured more than 100 patients of everything from Alzheimer’s disease to spinal cord injury. In fact, she claims to be able to cure more than twenty different diseases with treatments proven to be bogus. Her credentials are nowhere to be found. Multiple lawsuits against her exist’. This publication classifies NuTech Mediworld under ‘notorious stem cell operations: avoid, shun and ignore their claims’. Indeed, NuTech Mediworld and Dr. Shroff were apparently subject to a governmental inquiry in 2006; the results of that inquiry are not widely known (5).
In summary, ALSUntangled can find little objective information on the technical and safety aspects of NuTech Mediworlds’ stem cell treatment.
The main part of the treatment is alleged to be some type of embryonic cell line being injected into spinal fluid (and possibly other various body parts) without immunosuppressives; to our knowledge it has never been demonstrated that embryonic cell lines are safe, not to mention effective, for ALS when used in this way. We can find no information confirming Dr. Schroffs’ education and training to perform stem cell transplants. We can find no evidence that ALS diagnoses are being appropriately confirmed at NuTech, nor that adequate informed consent is being documented prior to treatment, nor that validated ALS outcomes are measured after treatment. We did find a number of unusual tests being performed there, as well as odd concurrent treatment for seronegative Lyme disease. For the one ALS patient in whom validated outcomes were available, there actually may have been a worsening rate of disease progression following NuTech treatment. We would welcome an opportunity to discuss our findings with Dr. Shroff and review any additional information that she can provide in order to provide as accurate and fair an assessment about NuTech Mediworld Stem cell treatments possible. We invite Dr. Shroff to write a letter to this journal, present her results at an international ALS meeting, or meet with us directly. Unless or until this occurs, ALSUntangled suggests that patients with ALS avoid NuTech Mediworld.