Alsuntangled No. 27: Precision Stem Cell

ISSN 2167-8421 print/ISSN 2167-9223 online © 2015 Informa Healthcare DOI: 10.3109/21678421.2015.1024571 into the extremity muscles and the spinal fl uid of the person who donated the fat. No safety or effi cacy outcome measures appear to have been objectively or systematically monitored. This description is similar to what two independent groups reported in their own reviews of PSC in early 2013 (9,10). Over the remainder of 2013, Williams apparently changed his protocol (7). On 20 August 2013 he told us that he had started to use umbilical-derived cells from donors without ALS, was working with “ gene therapy ” , and was testing image guided injections into the spinal cord and nerve roots (7). Our email requests for additional details on these changes have largely gone unanswered (7). With regard to the gene therapy, the PSC website notes a partnership with a company called Neuralgene (6). The Neuralgene website states that they use a virus (AAV) to deliver various genes to various tissues for patients with different diseases (11). For ALS, the website says: ‘ The AAV9 viral vector delivers multiple genes, which include Factor H (a regulator of complement activity), neural growth factors and regulators of TDP-43, to the neural cells ’ (12). The status of Neuralgene ’ s ALS product development program is unclear; animal studies of this gene therapy were reported to begin in May 2013 (12) but the website also claims: ‘ Neuralgene has initiated initial human testing in it ’ s gene therapy for ALS ’ (11). Typically, animal studies would be completed before human testing begins. A PubMed search identifi ed no published studies on Neuralgene protocols in animals or humans and there are no Neuralgene trials listed on ClinicalTrials.gov. Williams is listed as the CEO and director of R & D for Neuralgene (13). On 24 September 2014 Williams wrote: “ We are not doing much with stem cells anymore, mostly just a little orthopedic work ... .we tried aav, vegf, gdnf, igf2, but nothing exciting ” (7). ALSUntangled has been unable to obtain any additional details. According to the PSC website (6) and an email from Williams dated 7 October 2014, some form of MSC treatment is still being offered to patients with ALS (7). ALSUntangled reviews alternative and off-label treatments for patients with ALS (PALS). Here, we examine the treatment offered at Precision Stem Cell, for which we have had more than 1100 requests (1). This is the fi rst review that incorporates our new Table of Evidence (TOE, (2)). Precision Stem Cell (PSC) is a clinic formerly in Gulf Shores, Alabama now in Bogota, Columbia. It is led by Jason Williams, a radiologist (3). He uses imaging techniques such as MRI, CT, fl uoroscopy and ultrasound (4) to insert mesenchymal (meaning loosely packed in a gelatinous ground substance such as fat, umbilical cord or bone marrow) stem cells (MSCs) into patients with various ailments. This is primarily marketed toward athletes as a way to help them recover faster from musculoskeletal injuries (5).