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Cited by 234Mesenchymal stem cell researchPeriodontal Regeneration and TreatmentsOsteoarthritis Treatment and Mechanisms

Safety and Complications Reporting Update on the Re-Implantation of Culture-Expanded Mesenchymal Stem Cells Using Autologous Platelet Lysate Technique

J. Centeno, Christopher, R. Schultz, John, Cheever, Michelle, Freeman, Michael, Faulkner, Stephen, Robinson, Brent, Hanson, Ronald·2011·Current Stem Cell Research & Therapy
DOI 10.2174/157488811797904371
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Abstract

UNLABELLED: 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.

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Authors
J. Centeno, C., R. Schultz, J., Cheever, M., Freeman, M., Faulkner, S., Robinson, B., & Hanson, R.
ORCID
Freeman, Michael
Venue
Current Stem Cell Research & Therapy
Publisher
Bentham Science Publishers Ltd.
Published
2011-12-01
Volume
6
Issue
4
Pages
368-378
ISSN
1574-888X (ISSN-L)
DOI
10.2174/157488811797904371
OpenAlex
W2168562733
Cited by
234
References
43
Citations by year
2026: 2 · 2025: 3 · 2023: 6 · 2022: 3 · 2021: 9 · 2020: 9 · 2019: 21 · 2018: 18 · 2017: 24 · 2016: 22 · 2015: 28 · 2014: 25 · 2013: 28 · 2012: 18
FWCI
13.22
Type
journal article
Language
en
Open access
closed
Locations
  • Current Stem Cell Research & Therapy (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Genetics › Mesenchymal stem cell research
  • Health Sciences › Medicine › Urology › Periodontal Regeneration and Treatments
  • Health Sciences › Medicine › Rheumatology › Osteoarthritis Treatment and Mechanisms
Keywords
mesenchymal stem cells, bone marrow-derived stem cells, cell therapy safety, adverse events, tumor formation, orthopedic conditions, regenerative medicine, complication surveillance, fluoroscopy-guided injection
MeSH terms
Adult, Aged, Blood Platelets, Bone Marrow Cells, Drug Evaluation, Female, Fluoroscopy, Follow-Up Studies, Humans, Knee Joint, Longitudinal Studies, Magnetic Resonance Imaging, Male, Middle Aged, Prospective Studies, Surveys and Questionnaires, Replantation, Transplantation, Autologous, Treatment Outcome, Cell Culture Techniques, Orthopedic Procedures, Regenerative Medicine, Mesenchymal Stem Cell Transplantation, Mesenchymal Stem Cells

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