Clinical Trials Study
Copyright ©The Author(s) 2025. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Pediatr. Mar 9, 2025; 14(1): 96643
Published online Mar 9, 2025. doi: 10.5409/wjcp.v14.i1.96643
Autologous cord blood vs individualized supplements in autistic spectrum disorder: CORDUS study results
Felician A Stancioiu, Raluca Bogdan, Bogdan Ivanescu, Radu Dumitrescu
Felician A Stancioiu, Department of Clinical Research, Bio-Forum Foundation, Bucharest 040245, Bucuresti, Romania
Raluca Bogdan, Department of Pediatrics, Medicover Hospital Bucharest, Bucharest 013982, Bucuresti, Romania
Bogdan Ivanescu, Doctor MiT Clinic, Bucharest 013929, Bucuresti, Romania
Radu Dumitrescu, Department of Anesthesiology and Intensive Therapy, Medicover Hospital, Bucharest 013982, Bucuresti, Romania
Co-corresponding authors: Felician A Stancioiu and Radu Dumitrescu.
Author contributions: Stancioiu FA designed the clinical study and wrote the draft manuscript; Ivanescu B edited the manuscript; Bogdan R and Dumitrescu R edited and revised the manuscript; all authors have read and approve the final manuscript.
Institutional review board statement: The CORDUS Clinical Study received ethics approval from the National Bioethics Committee of the Romanian Medicine Agency ANM, No. IS/4/12.02.
Clinical trial registration statement: CORDUS clinical study is registered on www.clinicaltrials.gov with NCT04007224.
Informed consent statement: Informed Consent was obtained from all the children’s parents prior to enrolling and testing (both parents needed to agree on enrolment).
Conflict-of-interest statement: Stancioiu FA has received speaker honorariums and consultant fees from three family cord blood banks after the CORDUS study was designed and started; Ivanescu B is the medical director for a private cord blood bank; Bogdan R and Dumitrescu R have no conflicts of interest.
Data sharing statement: Testing the participants in the CORDUS clinical study has generated data from blood and cord blood analysis, including genetic-type testing, which are tabulated in Excel. Most of the data collected can be shared after removal of patient name, date of birth and other information based on which patients can be identified. Requests for sharing the anonymised study data should be made in writing to the corresponding author.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Felician A Stancioiu, MD, Doctor, Department of Clinical Research, Bio-Forum Foundation, Splai Unirii Nr 8, Parter, Bucharest 040245, Bucuresti, Romania. felicians@bio-forum.net
Received: May 11, 2024
Revised: October 3, 2024
Accepted: December 6, 2024
Published online: March 9, 2025
Processing time: 222 Days and 12.8 Hours
Abstract
BACKGROUND

Cellular therapies have started an important new therapeutic direction in autistic spectrum disorder (ASD), and the ample diversity of ASD pathophysiology and the different types of cell therapies prompt an equally ample effort to employ clinical studies for studying the ASD causes and cell therapies. Stem cells have yielded so far mixed results in clinical trials, and at patient level the results varied from impressive to no improvement. In this context we have administered autologous cord blood (ACB) and a non-placebo, material intervention represented by an individualized combination of supplements (ICS) to ASD children.

AIM

To compare the efficacy of ACB vs ICS and find markers correlated with the child's progress in order to better predict ACB efficacy.

METHODS

CORDUS clinical study is a crossover study in which both oral ICS and intravenous ACB were sequentially administered to 56 children; ACB was infused as an inpatient procedure. Treatment efficacy was evaluated pre-treatment and post-treatment at 6 months by an independent psychotherapist with Autism Treatment Evaluation Checklist, Quantitative Checklist for Autism in Toddlers and a 16-item comparative table score, after interviewing the children’s parents and therapists. Before and after each intervention participants had a set of blood tests including inflammatory, metabolic and oxidative markers, and the neuronal specific enolase.

RESULTS

No serious adverse reactions were noted during and after cord blood or supplement administration. ACB improved evaluation scores in 78% of children with age 3–7-years (n = 28), but was much less effective in kids older than 8 years or with body weight of more than 35 kg (n = 28; only 11% of children improved scores). ICS yielded better results than ACB in 5 cases out of 28, while in 23 kids ACB brought more improvement than ICS (P < 0.05); high initial levels of inflammation and ferritin were associated with no improvement. Ample individual differences were noted in children's progress, and statistically significant improvements were seen after ACB on areas such as verbalization and social interaction, but not on irritability or aggressive behavior.

CONCLUSION

ACB has superior efficacy to ICS in ASD; high inflammation, ferritin, age and body weight predict less improvement; more clinical studies are needed for studying ACB efficacy in ASD.

Keywords: Autistic spectrum disorder; Cord blood; Stem cells; Neuroinflammation; Autologous stem cell treatment; Neuronal specific enolase

Core Tip: CORDUS clinical study aimed to find factors correlated to therapeutic efficacy in autistic spectrum disorder (ASD) by comparing sequential administration of autologous cord blood (ACB) and individualised supplements and testing both the ASD children and the ACB. High initial levels of inflammation markers (erythrocyte sedimentation rate, C-reactive protein, tumor necrosis factor-alpha, α-2 globulins) or ferritin, but not high initial levels of neuronal specific enolase (NSE), were correlated with little or no improvement after cord blood administration. In some patients NSE was lowered after ACB. In a few patients improvement on specific supplements was superior to cord blood. Further studies are needed for finding predictors of cord blood efficacy in ASD.