Villarreal-Martínez Laura, González-Martínez Gerardo, Sáenz-Flores Melissa, Bautista-Gómez Andrea Judith, González-Martínez Adrián, Ortiz-Castillo Miguel, Robles-Sáenz David Alejandro, Garza-López Elizabeth
Hematology Service, Hospital UniversitariöDr. José Eleuterio González¨, Universidad Autónoma de Nuevo León, Nuevo León, Monterrey, México.
Plataforma INVEST Medicina UANL-KER Unit Mayo Clinic (KER Unit Mexico), Universidad Autónoma de Nuevo León, Monterrey, 64460, México.
Stem Cell Rev Rep. 2022 Jan;18(1):155-164. doi: 10.1007/s12015-021-10257-0. Epub 2021 Sep 13.
Assess the safety and efficacy of upcoming stem cell treatments and analyze their effects on the cognitive and behavioral impairments in patients diagnosed with autism.
We 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.
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.
Eleven 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.
The 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.
评估即将开展的干细胞治疗的安全性和有效性，并分析其对自闭症患者认知和行为障碍的影响。
我们纳入了对照和非对照、随机和非随机试验，这些试验评估了与安慰剂或无对照相比，干细胞疗法作为自闭症谱系障碍患者的一种治疗方法。
Scopus、科学网、MEDLINE和EMBASE。使用Cochrane偏倚风险工具和美国国立卫生研究院无对照组研究质量评估工具评估偏倚风险。
11项试验（包括461名患者）被证明符合条件。ABC量表荟萃分析显示干预组的平均原始得分是-11.97（95%置信区间-91.45至67.52，p<0.01）。CARS量表报告的平均原始得分是-9.08（95%置信区间-15.43至-2.73，p<0.01）。VABS量表按其领域报告：沟通领域报告的平均原始得分是2.69（95%置信区间1.30至4.08，p=0.92）；日常生活领域为1.99（95%置信区间0.83至3.15，p=0.51）；运动领域为1.06（95%置信区间-0.37至2.48，p=0.20）；社交领域为3.09（95%置信区间1.71至4.48，p=0.61）；适应行为领域为2.10（95%置信区间1.04至3.16，p=0.36）。此外，报告的最常见副作用包括发热、多动、呕吐、头痛和攻击性；未报告严重不良事件。
现有证据表明，干细胞疗法可显著改善自闭症谱系障碍患者的量表得分，因此，未来的研究应有助于我们对结果更有信心。我们未发现与干细胞疗法相关的严重不良事件。
