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Broomfield, CO, United States

The use of stem cells in orthopedics has been researched for many years, with robust animal data that show efficacy in cartilage healing, tendon repair, and intervertebral disk treatment. Early clinical data are also just starting to be published, and these results are encouraging. Safety data in large case series, some that lasted for many years, have also been published. The field of tissue engineering with stem cells in musculoskeletal impairments has the potential to reduce morbidity and improve clinical outcomes. The regulatory environment for this area of medicine is still developing. © 2014 American Academy of Physical Medicine and Rehabilitation. Source

Centeno C.J.,The Centeno Schultz Clinic | Bashir J.,The Centeno Schultz Clinic
PM and R

Stem cells therapies have been in preclinical development for the past 2 decades. A rapidly evolving regulatory landscape has restrained many of these technologies from advancing from the bench to the bedside. Although the large-scale clinical safety of stem cell therapies remains to be fully tested, the total number of patients who have safely received these therapies is large and growing. Prima facie evidence would dictate that certain types of cell therapy are likely safer than others. Understanding the current regulation regarding stem cells involves a discussion of their safety profile, as the 2 issues are closely intertwined. © 2015 American Academy of Physical Medicine and Rehabilitation. Source

Centeno C.J.,The Centeno Schultz Clinic | Fuerst M.,The Centeno Schultz Clinic | Faulkner S.J.,The Centeno Schultz Clinic | Freeman M.,The Centeno Schultz Clinic
Journal of Cosmetic Dermatology

In the area of cosmetic dermatology, some physicians have been injecting activated platelet-rich plasma into the face to promote cosmesis or using it to enhance fat grafts. However, subtle changes to the federal drug code (21 CFR 1271.1) made in 2004, when applied to activated PRP, purport to make this autologous substance a federally regulated drug requiring an extensive and costly Biologics License Application. Are autologous cells drugs? Many physicians believe there are significant problems with this regulatory paradigm. © 2011 Wiley Periodicals, Inc. Source

Centeno C.J.,The Centeno Schultz Clinic | Schultz J.R.,The Centeno Schultz Clinic | Cheever M.,The Centeno Schultz Clinic | Freeman M.,Oregon Health And Science University | And 3 more authors.
Current Stem Cell Research and Therapy

Mesenchymal stem cells (MSCs) hold great promise as therapeutic agents in regenerative medicine. Numerous animal studies have documented the multipotency of MSCs, showing their capabilities for differentiating into orthopedic tissues such as muscle, bone, cartilage, and tendon. However, the safety of culture expanded MSC's for human use has only just begun to be reported. Methods: Between 2006 and 2010, two groups of patients were treated for various orthopedic conditions with culture-expanded, autologous, bone marrow-derived MSCs (group 1: n=50; group 2: n=290-one patient in both groups). Cells were cultured in monolayer culture flasks using an autologous platelet lysate technique and re-injected into peripheral joints or into intervertebral discs with use of c-arm fluoroscopy. While both groups had prospective surveillance for complications, Group 1 additionally underwent 3.0T MRI tracking of the re-implant sites. Results: The mean age of patients treated was 53 +/- 13.85 years; 214 were males and 125 females with mean follow-up time from any procedure being 435 days +/- 261 days. Number of contacts initiated based on time from first procedure was 482 at 3 months, 433 at 6 months, 316 contacts at 12 months, 110 contacts at 24 months, and 22 contacts at 36 months. For Group 1, 50 patients underwent 210 MRI surveillance procedures at 3 months, 6 months, 1, 2, and 3 years which failed to demonstrate any tumor formation at the re-implant sites. Formal disease surveillance for adverse events based on HHS criteria documented significantly less morbidity than is commonly reported for more invasive surgical procedures, all of which were either self-limited or were remedied with therapeutic measures. Two patients were diagnosed with cancer out of 339 patients treated since study inception; however, this was almost certainly unrelated to the MSC therapy and the neoplasm rate in similar to that seen in the U.S. Caucasian population. Knee outcome data was collected on a subset of patients. Here, >75% improvement was reported in 41.4% while decreasing the improvement threshold to >50% improvement, 63.2% reported an improvement. At an average reporting time of 11.3 months from first procedure average reported relief in the knee sample equaled 53.1% (n=133 reporting). Conclusions: Using both intensive high field MRI tracking and complications surveillance in 339 patients, no neoplastic complications were detected at any stem cell re-implantation site. These findings are consistent with our prior publication and other published reports that also show no evidence of malignant transformation in vivo, following implantation of MSCs for orthopedic use. Source

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