Clinical Trial of Allogenic Umbilical Cord Mesenchymal Stem Cells - Conditioning Media (UCMSCs-CM) and Allogenic Umbilical Cord Mesenchymal Stem Cells (UCMSCs) in Children with Cerebral Palsy
Tahapan Penelitian : Recruit
Sponsor:
PT. Prodia StemCell Indonesia
Mitra Pelaksana:
Rumah Sakit Pusat Otak Nasional
No Registry
INA-626MPQO8
Tanggal Input Registry : 19-02-2025
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 23-10-2021 |
| Outcome Primer | Gross motor skills and cognitive abilities and nerve cell regeneration through measurable chemical factors. |
| Outcome Skunder | |
| Descriptive Information | |
| Judul Penelitian Popular | Clinical Trial of Allogenic Umbilical Cord Mesenchymal Stem Cells - Conditioning Media (UCMSCs-CM) and Allogenic Umbilical Cord Mesenchymal Stem Cells (UCMSCs) in Children with Cerebral Palsy |
| Judul Penelitian Ilmiah | Clinical Trial of Allogenic Umbilical Cord Mesenchymal Stem Cells - Conditioning Media (UCMSCs-CM) and Allogenic Umbilical Cord Mesenchymal Stem Cells (UCMSCs) in Children with Cerebral Palsy |
| Jenis Penelitian | Interventional |
| Intervensi | Group 1: UCMSC - receives allogenic umbilical cord mesenchymal stem cells (1 million cells/Kg body weight in 5 cc NaCl) Group 2: UCMSC + UCMSC CM - receives allogenic umbilical cord mesenchymal stem cells and conditioning media derived from UCMSCs (1 million cells/Kg body weight in 5 cc CM-UCMSC) Group 3: Control - no treatment |
| Jumlah Subyek Penelitian | 78 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: Patients diagnosed with CP aged 6 months to 3 years with total body involvement type, parents request stem cell therapy to be performed, parents provide written informed consent to undergo examinations, therapy, and blood sample collection, signed by both parents of the child.Exclusion Criteria: Head circumference is very small (more than 3 cm below -2 SD of the Nellhaus curve), has a history of meningitis or encephalitis, previously diagnosed with congenital infections such as toxoplasmosis, congenital rubella, or congenital cytomegalovirus, has been proven to have metabolic, chromosomal, congenital malformations, or neurodegenerative disorders, the disorder is progressive, the disorder involves developmental regression, and MRI results show severe anatomical damage |
| Administrative Information | |
| Nomor Persetujuan Etik | LB.02.01/KEP/058/2022 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | Not applicable |
| Other Study ID Numbers | |
| Contact Person | Rima Haifa,S,Si.,M.Farm-Klin |