Evidence map›Paper›PMID 37626416›Full record

Trial reportStem cell research & therapy2023

A novel therapeutic management for diabetes patients with chronic limb-threatening ischemia: comparison of autologous bone marrow mononuclear cells versus allogenic Wharton jelly-derived mesenchymal stem cells.

Martha L Arango-Rodríguez, Ligia C Mateus, Claudia L Sossa, Silvia M Becerra-Bayona, Víctor Alfonso Solarte-David, Miguel Enrique Ochoa Vera, Lady T Giratá Viviescas, Ana M Vera Berrio, Sergio Eduardo Serrano, Oliverio Vargas and 3 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Stem cell research & therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05631444 (Comparison of the Therapeutic Potential of Autologous Bone Marrow Mononuclear Cells Versus Allogenic Wharton Jelly-derived Mesenchymal Stem Cells in Diabetic Patients With Chronic Limb-threatening Ischemia), which is not on this map. Cited by 17 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 2 pooled it
6.9field-weighted citation impact, top 3% of its field
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.

NCT05631444 phase1 / phase2completednot on this map

Comparison of the Therapeutic Potential of Autologous Bone Marrow Mononuclear Cells Versus Allogenic Wharton Jelly-derived Mesenchymal Stem Cells in Diabetic Patients With Chronic Limb-threatening Ischemia

TypeinterventionalSponsorFundación Oftalmológica de Santander Clínica Carlos Ardila LulleRan2019 to 2022Enrolled24ConditionsChronic Limb-threatening Ischemia, Diabetes MellitusArmsCell-based therapy
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 2 syntheses or guidelines pooled it, 24 citations in OpenAlex.

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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

13 authors at 2 institutions in 1 country.

Martha L Arango-RodríguezBanco Multitejidos y Centro de Terapias Avanzadas, Clínica FOSCAL Internacional, 681004, Floridablanca, Colombia. martha.arango@foscal.com.co.ORCID http://orcid.org/0000-0003-0409-1512
Ligia C MateusFundación Oftalmológica de Santander Carlos Ardila Lulle, 681004, Floridablanca, Colombia.
Claudia L SossaFundación Oftalmológica de Santander Carlos Ardila Lulle, 681004, Floridablanca, Colombia.
Silvia M Becerra-BayonaFacultad de Ciencias de la Salud, Universidad Autónoma de Bucaramanga - UNAB, 681003, Bucaramanga, Colombia.
Víctor Alfonso Solarte-DavidFacultad de Ciencias de la Salud, Universidad Autónoma de Bucaramanga - UNAB, 681003, Bucaramanga, Colombia.
Miguel Enrique Ochoa VeraFacultad de Ciencias de la Salud, Universidad Autónoma de Bucaramanga - UNAB, 681003, Bucaramanga, Colombia.
Lady T Giratá ViviescasBanco Multitejidos y Centro de Terapias Avanzadas, Clínica FOSCAL Internacional, 681004, Floridablanca, Colombia.
Ana M Vera BerrioBanco Multitejidos y Centro de Terapias Avanzadas, Clínica FOSCAL Internacional, 681004, Floridablanca, Colombia.
Sergio Eduardo SerranoFacultad de Ciencias de la Salud, Universidad Autónoma de Bucaramanga - UNAB, 681003, Bucaramanga, Colombia.
Oliverio VargasFundación Oftalmológica de Santander Carlos Ardila Lulle, 681004, Floridablanca, Colombia.
Andrés Catalá IslaFundación Oftalmológica de Santander Carlos Ardila Lulle, 681004, Floridablanca, Colombia.
Alape BenitezFundación Oftalmológica de Santander Carlos Ardila Lulle, 681004, Floridablanca, Colombia.
Germán RangelFundación Oftalmológica de Santander Carlos Ardila Lulle, 681004, Floridablanca, Colombia.
Foscal Hospital · COUniversidad Autónoma de Bucaramanga · CO

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundChronic limb-threatening ischemia (CLTI) represents the final stage of peripheral arterial disease. Approximately one-third of patients with CLTI are not eligible for conventional surgical treatments. Furthermore, patients with advanced stage of CLTI are prone to amputation and death. Thus, an effective therapeutic strategy is urgently needed. In this context, autologous bone marrow mononuclear cell (auto-BM-MNC) and allogeneic mesenchymal stem cells represent a promising therapeutic approach for treating CLTI. In this study, we compared the safety and beneficial therapeutic effect of auto-BM-MNC versus allogeneic Wharton jelly-derived mesenchymal stem cells (allo-WJ-MSCs) in diabetic patients with CLTI.

methodsWe performed a randomized, prospective, double-blind and controlled pilot study. Twenty-four diabetic patients in the advanced stage of CLTI (4 or 5 in Rutherford's classification) and a transcutaneous oxygen pressure (TcPO

resultsNo adverse events were reported. Patients with CLTI who received auto-BM-MNC and allo-WJ-MSCs presented an improvement in Rutherford's classification, a significant increase in TcPO

conclusionsOur results showed that patients with CLTI treated with auto-BM-MNC and allo-WJ-MSCs conserved 100% of their limb during 12 months of the follow-up compared to the placebo group, where 60% of participants underwent limb amputation in different times. Furthermore, we observed a faster improvement in the allo-WJ-MSC group, unlike the auto-BM-MNC group. Trial registration This study was retrospectively registered at ClinicalTrials.gov (NCT05631444).

Indexed as

Diabetes MellitusMesenchymal Stem CellsWharton JellyBone MarrowChronic Limb-Threatening IschemiaHumansProspective StudiesAutologous bone marrow mononuclear cells and allogenic Wharton jelly-derived mesenchymal stem cellsCell therapyChronic limb-threatening ischemiaPeripheral arterial disease

Identifiers

PMID37626416
PMCPMC10464344
OpenAlexW4386162242

What Socratic 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 Socratic graph.