Evidence map›Paper›PMID 31652984›Full record

ReviewPharmaceutics2019

Principal Criteria for Evaluating the Quality, Safety and Efficacy of hMSC-Based Products in Clinical Practice: Current Approaches and Challenges.

Juan Antonio Guadix, Javier López-Beas, Beatriz Clares, José Luis Soriano-Ruiz, José Luis Zugaza, Patricia Gálvez-Martín

Registry-linked trialAbstract readReview
In one paragraph

Review in Pharmaceutics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07512362 (A Pilot Study to Assess the Effect of Adding 1 Infusion of Human Mesenchymal Stem Cells), which is not on this map. Cited by 33 papers.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT07512362 phase2recruitingnot on this mapstarted 2026, after this paper: background citation

A Pilot Study to Assess the Effect of Adding 1 Infusion of Human Mesenchymal Stem Cells (hMSC) to Patients Treated With Anti-Amyloid Monoclonal Antibodies Who Are Suffering From Mild Cognitive Impairment or Mild Alzheimer's Disease.

TypeinterventionalSponsorBernard (Barry) BaumelRan2026 to 2028Enrolled10ConditionsMild Cognitive Impairment, Early Alzheimer's Disease, AD-MCIArmshuman Mesenchymal Stem Cells
3 · Its place in the literature

Who cites it

33 citing papers in PubMed.

  1. Review
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  20. Potency Assays: The 'Bugaboo' of Stem Cell Therapy.Advances in experimental medicine and biology · 2023
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Juan Antonio GuadixDepartment of Animal Biology, Faculty of Sciences, University of Málaga, Instituto Malagueño de Biomedicina (IBIMA), Campus de Teatinos s/n, Málaga E-29071, Spain. jaguadix@uma.es.ORCID 0000-0002-4291-6645
Javier López-BeasAndalusian Center for Molecular Biology and Regenerative Medicine (CABIMER), University of Pablo de Olavide-University of Seville-CSIC, Seville 41092, Spain. javicucha@gmail.com.
Beatriz ClaresDepartment of Pharmacy and Pharmaceutical Technology, Faculty of Pharmacy, University of Granada, Granada E-18071, Spain. beatrizclares@ugr.es.ORCID 0000-0001-6126-7890
José Luis Soriano-RuizDepartment of Pharmacy and Pharmaceutical Technology, Faculty of Pharmacy, University of Granada, Granada E-18071, Spain. jlsoriano@correo.ugr.es.ORCID 0000-0001-9465-0538
José Luis ZugazaDepartment of Genetics, Physical Anthropology and Animal Physiology, University of the Basque Country, Leioa E-48940, Spain. joseluis.zugaza@ehu.es.
Patricia Gálvez-MartínDepartment of Pharmacy and Pharmaceutical Technology, Faculty of Pharmacy, University of Granada, Granada E-18071, Spain. galmafarma@gmail.com.ORCID 0000-0001-9724-8560

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Human Mesenchymal Stem Cells (hMSCs) play an important role as new therapeutic alternatives in advanced therapies and regenerative medicine thanks to their regenerative and immunomodulatory properties, and ability to migrate to the exact area of injury. These properties have made hMSCs one of the more promising cellular active substances at present, particularly in terms of the development of new and innovative hMSC-based products. Currently, numerous clinical trials are being conducted to evaluate the therapeutic activity of hMSC-based products on specific targets. Given the rapidly growing number of hMSC clinical trials in recent years and the complexity of these products due to their cellular component characteristics and medicinal product status, there is a greater need to define more stringent, specific, and harmonized requirements to characterize the quality of the hMSCs and enhance the analysis of their safety and efficacy in final products to be administered to patients. These requirements should be implemented throughout the manufacturing process to guarantee the function and integrity of hMSCs and to ensure that the hMSC-based final product consistently meets its specifications across batches. This paper describes the principal phases involved in the design of the manufacturing process and updates the specific technical requirements needed to address the appropriate clinical use of hMSC-based products. The challenges and limitations to evaluating the safety, efficacy, and quality of hMSCs have been also reviewed and discussed.

Indexed as

cell characterizationgood manufacturing practicemesenchymal stem cellsrelease criteria and manufacturing process

Identifiers

PMID31652984
PMCPMC6921040

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.