Safety of Cultured Autologous Adult Adipose Derived Mesenchymal Stem Cell Intravenous Infusion for CP

Cerebral Palsy Clinical Trial

Official title:

Safety of Cultured Autologous Adult Adipose Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Cerebral Palsy

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05018871
• Other study ID #: SC-8-GR-8-04
• Status: Suspended
• Phase: Phase 1
• Start date: December 2021
• Est. completion date: December 2025

Study information

• Verified date: August 2021
• Source: The Foundation for Orthopaedics and Regenerative Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial will study the safety and efficacy of intravenous infusion of cultured autologous adult adipose derived mesenchymal stem cells for the treatment of Cerebral Palsy

Description:

Studies have shown that stem cell treatment is safe and efficacious for the treatment of Cerebral Palsy (CP). This patient funded trial aims to study the safety and efficacy of intravenous infusion of cultured autologous adult adipose derived mesenchymal stem cells (AD-MSCs) for the treatment of CP. Patients with CP will receive a single intravenous infusion of AD-MSCs. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 15
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Diagnosis of Cerebral Palsy

Exclusion Criteria:

• Active infection

• 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

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Biological:
• autologous adipose derived mesenchymal stem cells
cultured autologous adult adipose derived mesenchymal stem cells

Locations

Country	Name	City	State
Greece	Mitera Hospital Athens Greece	Marousi

Sponsors (1)

Lead Sponsor	Collaborator
The Foundation for Orthopaedics and Regenerative Medicine

Country where clinical trial is conducted

Greece, 

References & Publications (5)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety (adverse events)	Clinical monitoring of possible adverse events or complications	Four year follow-up
Secondary	Efficacy: Gross Motor Function Measure (GMFM)	It will be completed for each follow up point	Four year follow-up