Safety of Cultured Autologous Adult Adipose Derived Mesenchymal Stem Cell Intrathecal Injection for SCI

Spinal Cord Injuries Clinical Trial

Official title:

Safety of Cultured Autologous Adult Adipose Derived Mesenchymal Stem Cell Intrathecal Injection for the Treatment of Spinal Cord Injury

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05018793
• Other study ID #: SC-8-GR-10-02
• 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 intrathecal injection of cultured autologous adult adipose derived mesenchymal stem cells for the treatment of spinal cord injury

Description:

Studies have shown that stem cell treatment is safe and efficacious for the treatment of spinal cord injury (SCI). This patient funded trial aims to study the safety and efficacy of intrathecal injection of cultured autologous adult adipose derived mesenchymal stem cells (AD-MSCs) for the treatment of SCI. Patients with SCI will receive a single intrathecal injection 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 Spinal Cord Injury
• Understanding and willingness to sign a written informed consent document

Exclusion Criteria:

• Active infection
• Active cancer
• Chronic multisystem organ failure
• Pregnancy
• Anticoagulation medicine use
• 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
• Hypersensitivity to sulfur
• Continued drug abuse
• Pre-menopausal women not using contraception

Related Conditions & MeSH terms

• Spinal Cord Injuries

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 (3)

Bydon M, Dietz AB, Goncalves S, Moinuddin FM, Alvi MA, Goyal A, Yolcu Y, Hunt CL, Garlanger KL, Del Fabro AS, Reeves RK, Terzic A, Windebank AJ, Qu W. CELLTOP Clinical Trial: First Report From a Phase 1 Trial of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells in the Treatment of Paralysis Due to Traumatic Spinal Cord Injury. Mayo Clin Proc. 2020 Feb;95(2):406-414. doi: 10.1016/j.mayocp.2019.10.008. Epub 2019 Nov 27. — View Citation

Hur JW, Cho TH, Park DH, Lee JB, Park JY, Chung YG. Intrathecal transplantation of autologous adipose-derived mesenchymal stem cells for treating spinal cord injury: A human trial. J Spinal Cord Med. 2016 Nov;39(6):655-664. Epub 2015 Jul 24. — View Citation

Roberts TT, Leonard GR, Cepela DJ. Classifications In Brief: American Spinal Injury Association (ASIA) Impairment Scale. Clin Orthop Relat Res. 2017 May;475(5):1499-1504. doi: 10.1007/s11999-016-5133-4. Epub 2016 Nov 4. — 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: American Spinal Injury Association Impairment Scale (ASIA)	It will be completed for each follow up point	Four year follow-up