JPRN-jRCTb040230042招募中1 期
A clinical trial to evaluate the safety and tolerability of stem cells from human exfoliated deciduous teeth in children with cerebral palsy.
Sato Yoshiaki0 个研究点目标入组 3 人开始时间: 2023年6月22日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 3
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 6age old 至 <= 11age old(—)
- 性别
- All
入选标准
- •1) Patients aged 6 to 11 who were diagnosed with cerebral palsy at a medical institution
- •2) Patients diagnosed with neonatal hypoxic-ischemic encephalopathy (HIE) at a medical institution
- •3) Patients with GMFCS level II or III
- •4) Patients with deciduous teeth that are slightly mobile or who have previously lost deciduous teeth
- •5) Patients with deciduous central or lateral incisors without cavity of C2 or higher
- •6) Patients who obtained written consent from the legal representative of the patient
排除标准
- •1) Patients participating in other clinical trials (excluding observational studies)
- •2) Patients with confirmed or suspected severe congenital abnormalities or chromosomal abnormalities
- •3) Patients who have been judged by the attending physician to be unable to extract a tooth with local anesthesia
- •4) Patients undergoing or scheduled to undergo tendonectomy within one year
- •5) Patients who received botulinum toxin injection within 6 months
- •6) Patients with active or suspected serious infections
- •7) Patients who are positive for HBs antigen, HCV antibody, HIV antibody, HTLV-1 antibody, or serologic test for syphilis
- •8) Patients diagnosed with diabetes
- •9) Patients with a history of severe hypersensitivity or anaphylactic reaction
- •10) Patients with other serious underlying diseases
- •11) Patients with liver or renal dysfunction
- •12) Patients who are judged to be inappropriate by the attending physician
研究者
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