What this study is
This trial will study the safety and efficacy of intrathecal injection of cultured allogeneic adult umbilical-cord or placental derived mesenchymal stem cells for the treatment of spinal cord injury
What's being tested
- Cultured Allogeneic Adult Umbilical-cord or Placental Derived Mesenchymal Stem Cell Intrathecal injection
Intervention · BIOLOGICAL
Cultured Allogeneic Adult Umbilical-cord or Placental Derived Mesenchymal Stem Cell Intrathecal injection
Study details
- Official title
- Safety of Cultured Allogeneic Adult Umbilical-cord or Placental Derived Mesenchymal Stem Cell Intrathecal Injection for the Treatment of Spinal Cord Injury
- Sponsor
- The Foundation for Orthopaedics and Regenerative Medicine
- Conditions
- Spinal Cord Injuries
- Enrolling
- 15 people
- Starts
- 2024-12-01
- Est. completion
- 2028-12
- Design
- Open-label, single group, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Sex ALLHealthy volunteers Not acceptedYou may qualify if
- Diagnosis of Spinal Cord Injury
- Understanding and willingness to sign a written informed consent document
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openContact for every open site
- Chadwick Prodromos, MD · Contact847-699-6810 ext. 202care@thepsci.com
Prodromos Stem Cell Institute
Naples, Florida, United States
Recruiting
1 site outside the US
Prodromos Stem Cell Institute
Athens, Greece
Recruiting
Study team
Sponsor
The Foundation for Orthopaedics and Regenerative Medicine
Study ID SC-8-GR-10-02
Principal investigator
Chadwick Prodromos, MD
The Foundation for Orthopaedics and Regenerative Medicine
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.