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

Primary Purpose

Spinal Cord Injuries

Status
Suspended
Phase
Phase 1
Locations
Greece
Study Type
Interventional
Intervention
autologous adipose derived mesenchymal stem cells
Sponsored by
The Foundation for Orthopaedics and Regenerative Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring spinal cord injury, SCI, stem cell treatment

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mitera Hospital Athens Greece

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Group

Arm Description

Single intrathecal injection of 100 million cells

Outcomes

Primary Outcome Measures

Safety (adverse events)
Clinical monitoring of possible adverse events or complications

Secondary Outcome Measures

Efficacy: American Spinal Injury Association Impairment Scale (ASIA)
It will be completed for each follow up point

Full Information

First Posted
August 19, 2021
Last Updated
October 7, 2021
Sponsor
The Foundation for Orthopaedics and Regenerative Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05018793
Brief Title
Safety of Cultured Autologous Adult Adipose Derived Mesenchymal Stem Cell Intrathecal Injection for SCI
Official Title
Safety of Cultured Autologous Adult Adipose Derived Mesenchymal Stem Cell Intrathecal Injection for the Treatment of Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Suspended
Why Stopped
Covid-19
Study Start Date
December 2021 (Anticipated)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Foundation for Orthopaedics and Regenerative Medicine

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
spinal cord injury, SCI, stem cell treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Single intrathecal injection of 100 million cells
Intervention Type
Biological
Intervention Name(s)
autologous adipose derived mesenchymal stem cells
Intervention Description
cultured autologous adult adipose derived mesenchymal stem cells
Primary Outcome Measure Information:
Title
Safety (adverse events)
Description
Clinical monitoring of possible adverse events or complications
Time Frame
Four year follow-up
Secondary Outcome Measure Information:
Title
Efficacy: American Spinal Injury Association Impairment Scale (ASIA)
Description
It will be completed for each follow up point
Time Frame
Four year follow-up

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chadwick Prodromos, MD
Organizational Affiliation
The Foundation for Orthopaedics and Regenerative Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mitera Hospital Athens Greece
City
Marousi
Country
Greece

12. IPD Sharing Statement

Citations:
PubMed Identifier
31785831
Citation
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.
Results Reference
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PubMed Identifier
26208177
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. doi: 10.1179/2045772315Y.0000000048. Epub 2015 Jul 24.
Results Reference
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PubMed Identifier
27815685
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. No abstract available.
Results Reference
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Learn more about this trial

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

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