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The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This trial was funded by the Spanish Ministry of Health and Social Policy (EC10/171).

Analysis of institutional authors

Fuentes, BCorresponding AuthorDe Lecinana, MaAuthorBorobia, AmAuthorDiez-Tejedor, EAuthor

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Final Results of Allogeneic Adipose Tissue-Derived Mesenchymal Stem Cells in Acute Ischemic Stroke (AMASCIS): A Phase II, Randomized, Double-Blind, Placebo-Controlled, Single-Center, Pilot Clinical Trial

Publicated to:CELL TRANSPLANTATION. 31 9636897221083863- - 2022-03-01 31(), DOI: 10.1177/09636897221083863

Authors: de Celis-Ruiz, Elena; Fuentes, Blanca; Alonso de Lecinana, Maria; Gutierrez-Fernandez, Maria; Borobia, Alberto M; Gutierrez-Zuniga, Raquel; Ruiz-Ares, Gerardo; Otero-Ortega, Laura; Laso-Garcia, Fernando; Carmen Gomez-de Frutos, Mari; Diez-Tejedor, Exuperio

Affiliations

Univ Autonoma Madrid, La Paz Univ Hosp, Hosp La Paz Inst Hlth Res IdiPAZ, Dept Clin Pharmacol, Madrid, Spain - Author
Univ Autonoma Madrid, La Paz Univ Hosp, Hosp La Paz Inst Hlth Res IdiPAZ, Dept Neurol,Neurol Sci & Cerebrovasc Res Lab, Gen Bldg,Level 11,Paseo Castellana 261, Madrid 28046, Spain - Author
Univ Autonoma Madrid, La Paz Univ Hosp, Hosp La Paz Inst Hlth Res IdiPAZ, Stroke Ctr, Gen Bldg,Level 11,Paseo Castellana 261, Madrid 28046, Spain - Author

Abstract

Acute ischemic stroke is currently a major cause of disability despite improvement in recanalization therapies. Stem cells represent a promising innovative strategy focused on reduction of neurologic sequelae by enhancement of brain plasticity. We performed a phase IIa, randomized, double-blind, placebo-controlled, single-center, pilot clinical trial. Patients aged >= 60 years with moderate to severe stroke (National Institutes of Health Stroke Scale [NIHSS] 8-20) were randomized (1:1) to receive intravenous adipose tissue-derived mesenchymal stem cells (AD-MSCs) or placebo within the first 2 weeks of stroke onset. The primary outcome was safety, evaluating adverse events (AEs), neurologic and systemic complications, and tumor development. The secondary outcome evaluated treatment efficacy by measuring modified Rankin Scale (mRS), NIHSS, infarct size, and blood biomarkers. We report the final trial results after 24 months of follow-up. Recruitment began in December 2014 and stopped in December 2017 after 19 of 20 planned patients were included. Six patients did not receive study treatment: two due to technical issues and four for acquiring exclusion criteria after randomization. The final study sample was composed of 13 patients (4 receiving AD-MSCs and 9 placebo). One patient in the placebo group died within the first week after study treatment delivery due to sepsis. Two non-treatment-related serious AEs occurred in the AD-MSC group and nine in the placebo group. The total number of AEs and systemic or neurologic complications was similar between the study groups. No injection-related AEs were registered, nor tumor development. At 24 months of follow-up, patients in the AD-MSC group showed a nonsignificantly lower median NIHSS score (interquartile range, 3 [3-5.5] vs 7 [0-8]). Neither treatment group had differences in mRS scores throughout follow-up visits up to month 24. Therefore, intravenous treatment with AD-MSCs within the first 2 weeks from ischemic stroke was safe at 24 months of follow-up.

Keywords

acute ischemic strokeallogeneic adipose tissue–derived mesenchymal stem cellsclinical trialsafetyAcute ischemic strokeAllogeneic adipose tissue-derived mesenchymal stem cellsAllogeneic adipose tissue–derived mesenchymal stem cellsClinical trialMetaanalysisSafetyStem cell therapyTherapy

Quality index

Bibliometric impact. Analysis of the contribution and dissemination channel

The work has been published in the journal CELL TRANSPLANTATION due to its progression and the good impact it has achieved in recent years, according to the agency WoS (JCR), it has become a reference in its field. In the year of publication of the work, 2022, it was in position 12/26, thus managing to position itself as a Q2 (Segundo Cuartil), in the category Transplantation. Notably, the journal is positioned en el Cuartil Q2 para la agencia Scopus (SJR) en la categoría Biomedical Engineering.

From a relative perspective, and based on the normalized impact indicator calculated from World Citations provided by WoS (ESI, Clarivate), it yields a value for the citation normalization relative to the expected citation rate of: 7.83. This indicates that, compared to works in the same discipline and in the same year of publication, it ranks as a work cited above average. (source consulted: ESI Nov 14, 2024)

This information is reinforced by other indicators of the same type, which, although dynamic over time and dependent on the set of average global citations at the time of their calculation, consistently position the work at some point among the top 50% most cited in its field:

  • Weighted Average of Normalized Impact by the Scopus agency: 7.38 (source consulted: FECYT Feb 2024)

Specifically, and according to different indexing agencies, this work has accumulated citations as of 2025-06-20, the following number of citations:

  • WoS: 34
  • Scopus: 48
  • OpenCitations: 45

Impact and social visibility

From the perspective of influence or social adoption, and based on metrics associated with mentions and interactions provided by agencies specializing in calculating the so-called "Alternative or Social Metrics," we can highlight as of 2025-06-20:

  • The use, from an academic perspective evidenced by the Altmetric agency indicator referring to aggregations made by the personal bibliographic manager Mendeley, gives us a total of: 101.
  • The use of this contribution in bookmarks, code forks, additions to favorite lists for recurrent reading, as well as general views, indicates that someone is using the publication as a basis for their current work. This may be a notable indicator of future more formal and academic citations. This claim is supported by the result of the "Capture" indicator, which yields a total of: 102 (PlumX).

With a more dissemination-oriented intent and targeting more general audiences, we can observe other more global scores such as:

  • The Total Score from Altmetric: 2.75.
  • The number of mentions on the social network X (formerly Twitter): 5 (Altmetric).

It is essential to present evidence supporting full alignment with institutional principles and guidelines on Open Science and the Conservation and Dissemination of Intellectual Heritage. A clear example of this is:

  • The work has been submitted to a journal whose editorial policy allows open Open Access publication.
  • Assignment of a Handle/URN as an identifier within the deposit in the Institutional Repository: https://repositorio.uam.es/handle/10486/712786

Leadership analysis of institutional authors

There is a significant leadership presence as some of the institution’s authors appear as the first or last signer, detailed as follows: First Author (de Celis-Ruiz, E) and Last Author (DIEZ TEJEDOR, EXUPERIO).

the author responsible for correspondence tasks has been FUENTES GIMENO, BLANCA EULALIA.