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For the large portion of patients with chronic musculoskeletal pain who fall into the chasm of not responding to noninvasive therapies but decline or are not candidates for joint or spine surgery, some clinicians are turning to autologous mesenchymal stem cell (MSC) therapy — and seeing benefits.
The evidence on the therapy’s efficacy is inconclusive, and the patient-reported levels of improvement typically fall short of a slam-dunk, but their reports of pain relief of at least 50% are relatively consistent — and in the challenging realm of chronic pain treatment, that’s getting somewhere, said Harry Adelson, ND, medical director of Docere Clinics in Park City, Utah.
“To put this into perspective, arthroscopic surgery has been shown to be no better than placebo or conservative medical treatment for arthritis of the knee,” he said “while autologous MSC therapy shows significant benefit 3 years out from treatment.”
In describing his experience with stem cell therapy for chronic pain during a featured talk at the American Academy of Pain Management (AAPM) 25th Annual Clinical Meeting, Dr. Adelson said an informal survey of 62 patients in his practice who had received the therapy for knee arthritis since 2012 showed the overall level of improvement to be 52.8% for women and 61.3% for men.
The average improvement for both sexes was 52% at 12 to 18 months and 68% 18 to 24 months out.
After only 1 treatment, the average improvement was 54%; for patients who had 2 treatments, the rate improved to 60%. It rose to 68% for 3 treatments.
“What was interesting was we found no significant difference among patients who were over 65 or under, nor did body mass index appear to make a difference,” Dr. Adelson said.
Dr. Adelson’s findings were consistent with the results published in January this year in the European Journal of Orthopedic Surgery and Traumatology.
In that study, among 41 patients with osteoarthritis of 75 knees who received bone marrow aspirate concentrate (BMAC)/whole adipose injection, visual analogue scale score decreased from 7.0 preoperatively to 4.1, 3.5, and 3.3 postoperatively at 3, 6, and 12 months.
The therapy is based on the potential healing capabilities of MSCs, which contain growth factors and signalling proteins that can instigate the regeneration of damaged tissue, Dr. Adelson explained.
“We’re taking stem cells from where they live and injecting them to where the problem is and then stepping back and letting nature take its course, allowing the body’s natural healing cascade to occur.”
The stem cells can be harvested and concentrated or isolated from bone marrow or fat, respectively, to be reinjected directly into damaged or degenerated tissues.
The therapy is most commonly used to treat such conditions as degenerative disc disease, desiccated discs, spinal stenosis (both central and foraminal), facet arthrosis, sacroiliac joint syndrome, osteoarthritis of any joint, and sports/overuse injuries, Dr. Adelson said.
While Dr. Adelson said he has seen “not a single serious adverse outcome” among the approximately 2000 patients he’s treated, he advised warning patients who undergo bone marrow aspiration from the posterior superior iliac spine not to lie on a hard floor or to do sit ups on a hard floor for at least 2 weeks to avoid formation of a painful spur.
Patients who undergo lipoaspiration for stromal vascular fraction can expect mild to moderate pain and soreness at the harvest site that can last 2 to 4 weeks, he added.
Research on the safety of the procedure includes a study of 101 patients with bone healing disorders (Orthop Rev [Pavia].2009;1:e32) showing that further surgery was needed in 2 patients, but there were no complications in terms of infections, excessive new bone formation, or morbidity regarding the bone marrow removal site.
In that study, 84 patients reported being satisfied or very satisfied with the result of the operation.
Dr. Adelson noted that some of his patients who received whole adipose grafts have experienced flare-ups, however, and similar reports from other practitioners prompted him to avoid the use of whole adipose.
“Ten percent of patients who got whole adipose injected experienced pain and swelling, which is why I no longer inject whole adipose,” he said.
“Patients choose between BMAC — a 60-cc bone marrow aspiration renders approximately 20K MSCs, or stromal vascular fraction (SVF-lipoaspiration and isolation of MSCs) which a 60-cc lipoaspiration renders approximately 3M MSCs.”
Dr. Adelson underscored that use of a C-arm fluoroscope for guidance in injecting has allowed him to substantially improve his technique in the tricky process of bone marrow aspiration, enabling the placement of the precise angle needed to obtain maximum cell counts.
“For the bone marrow aspirations it’s so much easier and safer with the C-arm,” he said. “My only regret is I didn’t begin using it sooner.”
Importantly, clinicians need to follow key steps in order for the procedure to constitute a tissue transfer in the eyes of the US Food and Drug Administration (FDA), as opposed to the administration of a drug: The treatment must be autologous (the donor and patient must be the same person); the cells can only be minimally manipulated, with no alteration of the cells’ relative biological characteristics: and the transfer must take place in the same day, with no storage of the cells overnight.
“As long as you adhere to those 3 criteria, the procedure is a tissue transfer and not a drug, but the moment you deviate from them, it’s considered a drug and the FDA will become very interested in what you’re doing,” Dr. Adelson emphasized.
Tom N. Watson, DPT, a physical therapist based in Bend, Oregon, and chair of the AAPM’s Education Committee, agreed that more research is needed to determine the efficacy of autologous stem cells for the treatment of chronic pain, but that findings such as Dr. Adelson’s give hope.
“The research is not very solid yet, but the anecdotal results appear to be quite promising.”
“So far, we haven’t been able to show in studies if there is regrowth of cartilage when you use this just in a joint or tendon. Various studies using MRI or x-ray show no improvement in the joint surface or otherwise a year after the procedure,” he said.
“Despite that, the patients report having less pain and that’s a big deal because if you’re out of pain, you’re functioning better and moving better walking and much happier.”