Safety of Cultured Autologous Adult Adipose Derived Mesenchymal Stem Cell Intravenous Infusion for CP
NCT ID: NCT05018871
Last Updated: 2025-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
PHASE1
15 participants
INTERVENTIONAL
2025-12-31
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment Group
Single intravenous infusion of 100 million cells
autologous adipose derived mesenchymal stem cells
cultured autologous adult adipose derived mesenchymal stem cells
Interventions
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autologous adipose derived mesenchymal stem cells
cultured autologous adult adipose derived mesenchymal stem cells
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Active cancer
* Chronic multisystem organ failure
* Pregnancy
* Clinically significant Abnormalities on pre-treatment laboratory evaluation
* Medical condition that would (based on the opinion of the investigator) compromise patient's safety
* Previous organ transplant
* Seizure disorder
* Hypersensitivity to sulfur
ALL
No
Sponsors
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The Foundation for Orthopaedics and Regenerative Medicine
OTHER
Responsible Party
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Principal Investigators
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Chadwick Prodromos, MD
Role: PRINCIPAL_INVESTIGATOR
The Foundation for Orthopaedics and Regenerative Medicine
Locations
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Mitera Hospital Athens Greece
Marousi, , Greece
Countries
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References
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Alotaibi M, Long T, Kennedy E, Bavishi S. The efficacy of GMFM-88 and GMFM-66 to detect changes in gross motor function in children with cerebral palsy (CP): a literature review. Disabil Rehabil. 2014;36(8):617-27. doi: 10.3109/09638288.2013.805820. Epub 2013 Jun 26.
Ko J, Kim M. Reliability and responsiveness of the gross motor function measure-88 in children with cerebral palsy. Phys Ther. 2013 Mar;93(3):393-400. doi: 10.2522/ptj.20110374. Epub 2012 Nov 8.
Huang L, Zhang C, Gu J, Wu W, Shen Z, Zhou X, Lu H. A Randomized, Placebo-Controlled Trial of Human Umbilical Cord Blood Mesenchymal Stem Cell Infusion for Children With Cerebral Palsy. Cell Transplant. 2018 Feb;27(2):325-334. doi: 10.1177/0963689717729379.
Min K, Song J, Kang JY, Ko J, Ryu JS, Kang MS, Jang SJ, Kim SH, Oh D, Kim MK, Kim SS, Kim M. Umbilical cord blood therapy potentiated with erythropoietin for children with cerebral palsy: a double-blind, randomized, placebo-controlled trial. Stem Cells. 2013 Mar;31(3):581-91. doi: 10.1002/stem.1304.
Liu X, Fu X, Dai G, Wang X, Zhang Z, Cheng H, Zheng P, An Y. Comparative analysis of curative effect of bone marrow mesenchymal stem cell and bone marrow mononuclear cell transplantation for spastic cerebral palsy. J Transl Med. 2017 Feb 24;15(1):48. doi: 10.1186/s12967-017-1149-0.
Other Identifiers
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SC-8-GR-8-04
Identifier Type: -
Identifier Source: org_study_id
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