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Objective: Assess the security and efficacy of upcoming stem cell remedies and analyze their effects on the cognitive and behavioral impairments in patients diagnosed with autism.

Methods: We included managed and noncontrolled, randomized and non-randomized trials evaluating stem cell therapy as a therapy in patients with autism spectrum disorder compared to placebo or with out comparator.

Data sources: Scopus, Web of Science, MEDLINE and EMBASE. Risk of bias was assessed using Cochrane's Risk of Bias software and the NIH's Quality Assessment Tool for Studies With No Control Group.

Results: Eleven trials including 461 patients proved eligible. ABC scale meta-analysis confirmed a mean uncooked of -11.97 within the intervention teams (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.

Conclusions: The body of evidence suggests that stem cell therapy significantly improves scales in patients with autism spectrum disorder, therefore, future research should help us have more confidence in the outcomes. We found no critical antagonistic events associated to the stem cell therapy.

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