Safety of Cultured Autologous Adult Adipose Derived Mesenchymal Stem Cell Versus Cultured Allogeneic Adult Umbilical-cord Derived Mesenchymal Stem Cell Intrathecal Injection for SCI
NCT ID: NCT05018793
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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RECRUITING
PHASE1
15 participants
INTERVENTIONAL
2024-12-01
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 intrathecal injection of 100 million cells
autologous adipose derived mesenchymal stem cells
cultured autologous adult adipose derived mesenchymal stem cells
AlloRx
Cultured Allogeneic Adult Umbilical-cord Derived Mesenchymal Stem Cell Intrathecal injection for
Interventions
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autologous adipose derived mesenchymal stem cells
cultured autologous adult adipose derived mesenchymal stem cells
AlloRx
Cultured Allogeneic Adult Umbilical-cord Derived Mesenchymal Stem Cell Intrathecal injection for
Eligibility Criteria
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Inclusion Criteria
* Understanding and willingness to sign a written informed consent document
Exclusion Criteria
* 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
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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Medical Surgical Associates Center
St John's, , Antigua and Barbuda
Athens Beverly Hills Medical Group
Glyfada, Athens, Greece
Countries
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Facility Contacts
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Chadwick Prodromos, MD
Role: backup
References
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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.
Other Identifiers
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SC-8-GR-10-02
Identifier Type: -
Identifier Source: org_study_id
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