Evidence map›Paper›PMID 27999600›Full record

ReviewStem cells international2016

Mesenchymal Stem Cells as Therapeutics Agents: Quality and Environmental Regulatory Aspects.

Patricia Galvez-Martin, Roger Sabata, Josep Verges, José L Zugaza, Adolfina Ruiz, Beatriz Clares

Registry-linked trialAbstract readReview
In one paragraph

Review in Stem cells international, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04444245 (Re-establishment of Ovarian Hormonal Function, Delay of Menopause, or Reversal of Early Menopause With High Density), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing 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.

NCT04444245 phase1unknown statusnot on this mapstarted 2022, after this paper: background citation

Re-establishment of Ovarian Hormonal Function, Delay of Menopause, or Reversal of Early Menopause With High Density (HD PRP), tSVF + PRP, or Cell Enriched tSVF + PRP by Ultrasound Guided Ovarian Injection

TypeinterventionalSponsorBlack Tie Medical, Inc.Ran2022 to 2025Enrolled100ConditionsOvarian Failure, Perimenopausal Disorder, Hormone DisturbanceArmslipoaspiration harvest tSVF, Platelet Rich Plasma, Endovaginal Ultrasound, Cellular Isolation cSVF, Normal Saline (NS) .9% 10 mL Injection
3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Review
  6. Effects of VEGFStem cell reviews and reports · 2019
    Article
  7. Article
  8. 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.

Patricia Galvez-MartinAdvanced Therapies Area, Bioibérica S.A., 08029 Barcelona, Spain; Department of Pharmacy and Pharmaceutical Technology, School of Pharmacy, University of Granada, 180171 Granada, Spain.ORCID 0000-0001-9724-8560
Roger SabataAdvanced Therapies Area, Bioibérica S.A., 08029 Barcelona, Spain.
Josep VergesAdvanced Therapies Area, Bioibérica S.A., 08029 Barcelona, Spain.
José L ZugazaDepartment of Genetics, Physical Anthropology and Animal Physiology, University of the Basque Country, 48940 Leioa, Spain; Achucarro Basque Center for Neuroscience, Bizkaia Science and Technology Park, Building No. 205, 48170 Zamudio, Spain; IKERBASQUE, Basque Foundation for Science, María Díaz de Haro 3, 48013 Bilbao, Spain.
Adolfina RuizDepartment of Pharmacy and Pharmaceutical Technology, School of Pharmacy, University of Granada, 180171 Granada, Spain.
Beatriz ClaresDepartment of Pharmacy and Pharmaceutical Technology, School of Pharmacy, University of Granada, 180171 Granada, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Mesenchymal stem cells (MSCs) are one of the main stem cells that have been used for advanced therapies and regenerative medicine. To carry out the translational clinical application of MSCs, their manufacturing and administration in human must be controlled; therefore they should be considered as medicine: stem cell-based medicinal products (SCMPs). The development of MSCs as SCMPs represents complicated therapeutics due to their extreme complex nature and rigorous regulatory oversights. The manufacturing process of MSCs needs to be addressed in clean environments in compliance with requirements of Good Manufacturing Practice (GMP). Facilities should maintain these GMP conditions according to international and national medicinal regulatory frameworks that introduce a number of specifications in order to produce MSCs as safe SCMPs. One of these important and complex requirements is the environmental monitoring. Although a number of environmental requirements are clearly defined, some others are provided as recommendations. In this review we aim to outline the current issues with regard to international guidelines which impact environmental monitoring in cleanrooms and clean areas for the manufacturing of MSCs.

Identifiers

PMID27999600
PMCPMC5143779

What OpenQuestion holds

Textmetadata
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.