Largest Orthopedic Stem Cell Safety Paper Published!
Dr. Chris Centeno
It's funny, this evening I was sitting down to update our bigger bone marrow stem cell research in orthopedics inforgraphic up through spring of 2016 and the first paper that pops up is our n=2,372 safety paper. I knew that the publisher had in the queue, but you never know when these things will hit PubMed. I think this is the largest safety paper with the longest follow-up for MSC and BMC treated patients in any area, so correct me if you know of a bigger one. Of note, it compares complications from MSC, BMC, and BMC+adipose.
http://www.ncbi.nlm.nih.gov/pubmed/27026621
Abstract
Send to:
Int Orthop. 2016 Mar 30. [
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.
Centeno CJ1, Al-Sayegh H2, Freeman MD3,4, Smith J5, Murrell WD6, Bubnov R7.
Author information
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 post-procedure (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 follow-up. There was no clinical evidence to suggest that treatment with MSCs of any type in this study increased the risk of neoplasm.
KEYWORDS:
Bone marrow concentrate; Complications; Mesenchymal stem cells; Platelet rich plasma; Registry; Side effects
Dr. Chris Centeno
It's funny, this evening I was sitting down to update our bigger bone marrow stem cell research in orthopedics inforgraphic up through spring of 2016 and the first paper that pops up is our n=2,372 safety paper. I knew that the publisher had in the queue, but you never know when these things will hit PubMed. I think this is the largest safety paper with the longest follow-up for MSC and BMC treated patients in any area, so correct me if you know of a bigger one. Of note, it compares complications from MSC, BMC, and BMC+adipose.
http://www.ncbi.nlm.nih.gov/pubmed/27026621
Abstract
Send to:
Int Orthop. 2016 Mar 30. [
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.
Centeno CJ1, Al-Sayegh H2, Freeman MD3,4, Smith J5, Murrell WD6, Bubnov R7.
Author information
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 post-procedure (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 follow-up. There was no clinical evidence to suggest that treatment with MSCs of any type in this study increased the risk of neoplasm.
KEYWORDS:
Bone marrow concentrate; Complications; Mesenchymal stem cells; Platelet rich plasma; Registry; Side effects