- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05018793
Safety of Cultured Autologous Adult Adipose Derived Mesenchymal Stem Cell Intrathecal Injection for SCI
October 7, 2021 updated by: The Foundation for Orthopaedics and Regenerative Medicine
Safety of Cultured Autologous Adult Adipose Derived Mesenchymal Stem Cell Intrathecal Injection for the Treatment of Spinal Cord Injury
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
Study Overview
Status
Suspended
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Anticipated)
15
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Marousi, Greece
- Mitera Hospital Athens Greece
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment Group
Single intrathecal injection of 100 million cells
|
cultured autologous adult adipose derived mesenchymal stem cells
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety (adverse events)
Time Frame: Four year follow-up
|
Clinical monitoring of possible adverse events or complications
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Four year follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy: American Spinal Injury Association Impairment Scale (ASIA)
Time Frame: Four year follow-up
|
It will be completed for each follow up point
|
Four year follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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. doi: 10.1179/2045772315Y.0000000048. Epub 2015 Jul 24.
- 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. No abstract available.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
December 1, 2021
Primary Completion (Anticipated)
December 1, 2025
Study Completion (Anticipated)
December 1, 2025
Study Registration Dates
First Submitted
August 19, 2021
First Submitted That Met QC Criteria
August 19, 2021
First Posted (Actual)
August 24, 2021
Study Record Updates
Last Update Posted (Actual)
October 15, 2021
Last Update Submitted That Met QC Criteria
October 7, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SC-8-GR-10-02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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