A multi-center analysis of adverse events among two thousand, three hundred and seventy two adult patients undergoing adult autologous stem cell therapy for orthopaedic conditions

Abstract

Introduction The purpose of the present investigation is to report on detailed complications among a much larger group of 2372 orthopaedic patients treated with stem cell injections who were followed in a treatment registry for up to nine years. Methods All patients underwent an MSC-based, percutaneous injection treatment of an orthopaedic condition between December 2005 and September 2014 at one of 18 clinical facilities. Treated areas of the body included the knee, hip, ankle/foot, hand/wrist, elbow, shoulder, and spine. The patients were followed prospectively via enrollment in a treatment registry. Patients were followed prospectively at one, three, six and 12 months, and annually thereafter, using an electronic system, ClinCapture software.Results A total of 3012 procedures were performed on 2372 patients with follow-up period of 2.2 years. A total of 325 adverse events were reported. The majority were pain postprocedure (n = 93, 3.9 % of the study population) and pain due to progressive degenerative joint disease (n = 90, 3.8 % of the study population). Seven cases reported neoplasms, a lower rate than in the general population. The lowest rate of adverse events was observed among patients injected with BMC alone. Conclusion Lowest rate of adverse events was among those patients receiving BMC injections alone, but the higher rate of AEs for BMC plus adipose and cultured cells was readily explained by the nature of the therapy or the longer followup. There was no clinical evidence to suggest that treatment Electronic supplementary material The online version of this article

Concepts in regenerative medicine: Past, present, and future in articular cartilage treatment

“…[35][36][37][38] The basis for intervention has been the interpretation of stem cell therapies as high-risk biologic treatments despite data to the contrary. 10,12,21,22,39 Although an increasing number of warning letters to multiple clinics have been sent by the FDA, there are still numerous facilities that are operational and offering a full range of treatments to include administration of culture expanded cells, SVF delivered by intraarticular, intravenous, epidural, intra-discal, as well intrathecal transplantations. The US-FDA divides biologic therapies into low-risk and high-risk therapies by determining if the product has undergone minimal manipulation and autologous use (Fig.…”

“…19,20 This progression consisted of injecting all sorts of agents that induce a biological response, including: dextrose, sodium bicarbonate/calcium gluconate, hyaluronic acid, platelet rich plasma (PRP), bone marrow aspirate concentrate (BMAC), nano or micronized fat, adipose-stromal vascular fraction (A-SVF), culture expanded meschymal stem cells (CE-MSCs) both allogenic as well as autologous from a multitude of sources are becoming more commonplace. 16 The aggregate number and quality of studies are steadily improving, it is no doubt that the application of the cells are safe 10,12,21,22 and efficacious. 16 …”

Efficacy of Fenugreek-based bionanocomposite on renal dysfunction and endogenous intoxication in high-calorie diet-induced obesity rat model—comparative study

“…Hybrid techniques with regenerative and nanomedicine are very interesting and promising applications, in particular using nanoparticles capable of reducing the level of oxidative stress against metabolic syndrome and during aging [84]. Repair/regenerative capacity of using stem cell-based therapies, recently demonstrating high level of efficacy and safety [85], could improve the outcomes in patients with CKD [86].…”

Cellular therapy, an autologous cellular point of care approach to satisfy patient needs

“…A consequence of this restrictive philosophy, even not consumer friendly policy, in certain countries is, that it favours the growing international medical tourism and the loss of new applied medical PoC know-how in over-regulated countries, while patients wonder each time more why they cannot have the same treatment in their home country [1][2][3][4][5][6][7][8][9].…”