SHED for cerebral palsy

Phase 1

Recruiting

• Conditions: Cerebral Palsy (chronic stage); Cerebral Palsy

• Registration Number: JPRN-jRCTb040230042
• Lead Sponsor: Sato Yoshiaki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-06-22
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Safety assessment<br>1) Adverse events after tooth extraction and at 12 weeks, 24 weeks, and 52 weeks after administration<br>2) The following safety endpoints at each visit from the day of tooth extraction to 52 weeks after administration<br>-general condition<br>-12-lead ECG<br>-Oxygen saturation<br>-Subjective and objective symptoms<br>-Blood test (hematological test, blood biochemical test, coagulation test)<br>-Chest X-ray<br>-Echocardiography<br><br>Efficacy assessment<br>-MRI (imaging evaluation)<br>-GMFCS (motor function evaluation)<br>-GMFM-66 (motor function evaluation)<br>-Modified Ashworth Scale: MAS (muscle tone assessment)<br>-Gait analysis (motor function evaluation)<br>-WISC-IV (Intelligence test)