JPRN-jRCTb040230042
Recruiting
Phase 1
A clinical trial to evaluate the safety and tolerability of stem cells from human exfoliated deciduous teeth in children with cerebral palsy.
Sato Yoshiaki0 sites3 target enrollmentJune 22, 2023
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Sato Yoshiaki
- Enrollment
- 3
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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