Evidence map›Paper›PMID 34515938›Full record

SynthesisStem cell reviews and reports2022

Stem Cell Therapy in the Treatment of Patients With Autism Spectrum Disorder: a Systematic Review and Meta-analysis.

Laura Villarreal-Martínez, Gerardo González-Martínez, Melissa Sáenz-Flores, Andrea Judith Bautista-Gómez, Adrián González-Martínez, Miguel Ortiz-Castillo, David Alejandro Robles-Sáenz, Elizabeth Garza-López

Registry-linked trialAbstract readMeta-AnalysisSystematic Review
PubMed Publisher
In one paragraph

Synthesis in Stem cell reviews and reports, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07546942 (Autism Spectral Disorder), which is not on this map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
2.6field-weighted citation impact, top 10% 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.

NCT07546942 phase1 / phase2enrolling by invitationnot on this mapstarted 2026, after this paper: background citation

Autism Spectral Disorder (ASD) In Adolescent-Adults Treated by Multimodal Protocol: IV Autologous cSVF, Interval IV Autologous MSCs (Cryopreserved), Strick Ketogenic Diet RESET Program, and Fecal Microbiota Transplantation (FMT)

TypeinterventionalSponsorBlack Tie Medical, Inc.Ran2026 to 2030Enrolled50ConditionsAutism Spectrum Disorder, Autism, Autism Spectral DisorderArmsAutologous MSC isolation, concentration, and cryopreservation of adult mesenchymal stem cells, Fecal Biomicrome Transplantation (FMT), Ketogenic RESET Diet Protocol, Trial combines use of cSVF and MSCs (cryopres) with diet modification and FMT (fecal material Transplant in adult ASD patients, FMT (Fecal Material Tranplantation)
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 1 synthesis or guideline pooled it, 29 citations in OpenAlex.

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  3. Autologous cord bloodWorld journal of clinical pediatrics · 2025
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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

8 authors at 1 institution in 1 country.

Laura Villarreal-MartínezHematology Service, Hospital UniversitariöDr. José Eleuterio González¨, Universidad Autónoma de Nuevo León, Nuevo León, Monterrey, México. drlaura.villarrealmtz@gmail.com.ORCID 0000-0003-0313-7312
Gerardo González-MartínezHematology Service, Hospital UniversitariöDr. José Eleuterio González¨, Universidad Autónoma de Nuevo León, Nuevo León, Monterrey, México.
Melissa Sáenz-FloresPlataforma INVEST Medicina UANL-KER Unit Mayo Clinic (KER Unit Mexico), Universidad Autónoma de Nuevo León, Monterrey, 64460, México.
Andrea Judith Bautista-GómezHematology Service, Hospital UniversitariöDr. José Eleuterio González¨, Universidad Autónoma de Nuevo León, Nuevo León, Monterrey, México.
Adrián González-MartínezHematology Service, Hospital UniversitariöDr. José Eleuterio González¨, Universidad Autónoma de Nuevo León, Nuevo León, Monterrey, México.
Miguel Ortiz-CastilloHematology Service, Hospital UniversitariöDr. José Eleuterio González¨, Universidad Autónoma de Nuevo León, Nuevo León, Monterrey, México.
David Alejandro Robles-SáenzHematology Service, Hospital UniversitariöDr. José Eleuterio González¨, Universidad Autónoma de Nuevo León, Nuevo León, Monterrey, México.
Elizabeth Garza-LópezPlataforma INVEST Medicina UANL-KER Unit Mayo Clinic (KER Unit Mexico), Universidad Autónoma de Nuevo León, Monterrey, 64460, México.
Universidad Autónoma de Nuevo León · MX

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveAssess the safety and efficacy of upcoming stem cell treatments and analyze their effects on the cognitive and behavioral impairments in patients diagnosed with autism.

methodsWe included controlled and noncontrolled, randomized and non-randomized trials evaluating stem cell therapy as a treatment in patients with autism spectrum disorder compared to placebo or without comparator. DATA SOURCES: Scopus, Web of Science, MEDLINE and EMBASE. Risk of bias was assessed using Cochrane's Risk of Bias tool and the NIH's Quality Assessment Tool for Studies With No Control Group.

resultsEleven trials including 461 patients proved eligible. ABC scale meta-analysis showed a mean raw of -11.97 in the intervention groups (95 % CI -91.45 to 67.52, p < 0.01). CARS scale reported a mean raw of -9.08 (95 % CI -15.43 to -2.73, p < 0.01). VABS scale was reported by their domains: communication domain reported a mean raw of 2.69 (95 % CI 1.30 to 4.08, p = 0.92); daily living domain, 1.99 (95 % CI 0.83 to 3.15, p = 0.51); motor domain, 1.06 (95 % CI -0.37 to 2.48, p = 0.20); socialization domain, 3.09 (95 % CI 1.71 to 4.48, p = 0.61); adaptive behavior domain, 2.10 (95 % CI 1.04 to 3.16, p = 0.36). Furthermore, the most common side effects reported included fever, hyperactivity, vomit, headache, and aggressiveness; no serious adverse events were reported.

conclusionsThe body of evidence suggests that stem cell therapy significantly improves scales in patients with autism spectrum disorder, hence, future studies should help us have more confidence in the results. We found no serious adverse events related to the stem cell therapy.

Indexed as

Autism Spectrum DisorderCell- and Tissue-Based TherapyHumansAutismAutistic disorderMeta-analysisStem cellsStem cell transplantationSystematic review

Identifiers

PMID34515938
OpenAlexW3198986099

What OpenQuestion holds

Textmetadata
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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.