臨床研究等提出・公開システム

A clinical trial to evaluate the safety and tolerability of stem cells from human exfoliated deciduous teeth in children with cerebral palsy.

SHED for cerebral palsy

Maruyama Shoichi

Sato Yoshiaki

Nagoya University Hospital

65 Tsurumai-cho, Showa-ku, Nagoya, Aichi

shedcp@med.nagoya-u.ac.jp

Ieda Sachiko

Nagoya University Hospital

65 Tsurumai-cho, Showa-ku, Nagoya, Aichi

+81-52-744-2953

shedcp@med.nagoya-u.ac.jp

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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 primary teeth that have no caries of C2 or higher and whose dental X-rays show that permanent teeth are about to erupt.
5) Patients who obtained written consent from the legal representative of the patient

1) Patients participating in other clinical trials (excluding observational studies)
2) Patients with confirmed or suspected severe congenital abnormalities or chromosomal abnormalities
3) Patients without multiple primary teeth (excluding cases of re-registration)
4) Patients who have been judged by the attending physician to be unable to extract a tooth with local anesthesia
5) Patients undergoing or scheduled to undergo tendonectomy within one year
6) Patients who received botulinum toxin injection within 6 months
7) Patients with active or suspected serious infections
8) Patients who are positive for HBs antigen, HCV antibody, HIV antibody, HTLV-1 antibody, or serologic test for syphilis
9) Patients diagnosed with diabetes
10) Patients with a history of severe hypersensitivity or anaphylactic reaction
11) Patients with other serious underlying diseases
12) Patients with liver or renal dysfunction
13) Patients who are judged to be inappropriate by the attending physician

Both

Cerebral Palsy (chronic stage)

Stem cells from human exfoliated deciduous teeth

Single intravenous administration of human autologous stem cells from exfoliated deciduous teeth

Cerebral Palsy

Adverse events at 1 day, 3 days, 2 weeks, and 4 weeks after administration

Safety assessment
1) Adverse events after tooth extraction and at 12 weeks, 24 weeks, and 52 weeks after administration
2) The following safety endpoints at each visit from the day of tooth extraction to 52 weeks after administration
-general condition
-12-lead ECG
-Oxygen saturation
-Subjective and objective symptoms
-Blood test (hematological test, blood biochemical test, coagulation test)
-Chest X-ray
-Echocardiography

Efficacy assessment
-MRI
-motor function assessment (GMFCS, GMFM-66)
-muscle tone assessment (Modified Ashworth Scale: MAS)
-Limb joint range of motion assessment
-Gait analysis
-Physical function assessment
-Intelligence test (WISC-V)
-Kyoto Scale of Psychological Development
-Vineland adaptive behavior scales: II

Not Recruiting

+81-52-744-2479

June. 15, 2023