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Cited by 34Biomedical Ethics and RegulationEthics in Clinical ResearchHealthcare Regulation

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Overcoming barriers to facilitate the regulation of multi-centre regenerative medicine clinical trials

Open access
Kleiderman, Erika, Boily, Audrey, Hasilo, Craig, Knoppers, Bartha Maria·2018·Stem Cell Research & Therapy
DOI 10.1186/s13287-018-1055-2PMC PMC6225696
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Abstract

In the context of regenerative medicine and cellular therapies, the treatment under study often targets a less common disease or condition for which recruitment of a large number of research participants at any given site is challenging, if not impossible. One way to overcome this challenge is with a multi-centre clinical trial. This manuscript first aims to briefly outline the existing ethical, legal and social implications as well as the regulatory frameworks associated with multi-centre regenerative medicine clinical trials. Second, it considers the regulatory limitations and barriers surrounding the initiation of such trials in Canada, the USA and Europe. Third, it concludes with a set of recommendations for facilitating multi-centre clinical trials, at both national and international levels.

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  • Self-assembling peptide hydrogels provide a bioactive matrix that facilitates tissue repair, offering a promising solution for tendon and cartilage defects.

    “Moreover, self-assembling peptide hydrogels have been developed to provide a bioactive matrix that facilitates tissue repair, offering a promising solution for tendon and cartilage defects [122].”

    From Advancements in Regenerative Therapies for Orthopedics: A Comprehensive Review of Platelet-Rich Plasma, Mesenchymal Stem Cells, Peptide Therapies, and Biomimetic Applications (2025) · cites this paper as [122]

    The Background and Conclusions discuss cell-based therapies and barriers to multi-centre regenerative-medicine trials, not peptide hydrogels. Searches of our copy for self-assembling peptide hydrogels, bioactive matrices, and tendon or cartilage repair found no passage addressing the attributed claim; no page numbers were available. (LLM, conf=0.78)

    Experimental — accuracy not yet measured

  • Heterogeneity in study methodologies-particularly in PRP preparation, MSC sourcing, and peptide dosing-poses a challenge in drawing definitive conclusions regarding treatment efficacy.

    “Additionally, heterogeneity in study methodologies-particularly in PRP preparation, MSC sourcing, and peptide dosing-poses a challenge in drawing definitive conclusions regarding treatment efficacy [122,123].”

    From Advancements in Regenerative Therapies for Orthopedics: A Comprehensive Review of Platelet-Rich Plasma, Mesenchymal Stem Cells, Peptide Therapies, and Biomimetic Applications (2025) · cites this paper as [122]

    The Background discusses pooling resources across multicentre trials to generate conclusions, while the Limitations section discusses regulatory and logistical differences between sites. Neither addresses whether variation in PRP preparation, MSC sourcing, or peptide dosing makes treatment efficacy difficult to assess. Searches for those terms and for methodological variability affecting efficacy conclusions found no supporting passage in our copy. (LLM, conf=0.75)

    Experimental — accuracy not yet measured

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Metadata

Authors
Kleiderman, E., Boily, A., Hasilo, C., & Knoppers, B. M.
Affiliations
McGill University (CA)
Corresponding author
Kleiderman, Erika
ORCID
Venue
Stem Cell Research & Therapy
Publisher
Springer Science and Business Media LLC
Published
2018-11-08
Volume
9
Issue
1
Pages
307-307
ISSN
1757-6512 (ISSN-L)
DOI
10.1186/s13287-018-1055-2
PMC
PMC6225696
OpenAlex
W2899862245
Cited by
34
References
2
Citations by year
2026: 3 · 2025: 3 · 2023: 4 · 2022: 7 · 2021: 9 · 2020: 6 · 2019: 1
FWCI
0.53
Type
journal article
Language
en
Open access
Licence
Locations
  • Stem Cell Research & Therapy (publishedVersion, cc-by)
  • Europe PMC (PubMed Central) (publishedVersion, other-oa)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Funders
CellCAN – Regenerative Medicine and Cell Therapy Network (N/A)
Topics
  • Health Sciences › Nursing › Issues, ethics and legal aspects › Biomedical Ethics and Regulation
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Healthcare Regulation
Keywords
regenerative medicine, cell therapy, clinical trial regulation, regulatory challenges, participant recruitment, ethical, legal and social implications, international regulatory harmonization, Canada, Europe
MeSH terms
Clinical Trials as Topic, Humans, Social Control, Formal, Multicenter Studies as Topic, Regenerative Medicine

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