Spinal Cord InjuriesPhase 1NCT05018793
Safety of Cultured Allogeneic Adult Umbilical-cord or Placental Derived Mesenchymal Stem Cell Intrathecal Injection for SCI
A Phase 1 study testing Cultured Allogeneic Adult Umbilical-cord or Placental Derived Mesenchymal Stem Cell Intrathecal injection in people with Spinal Cord Injuries, run by The Foundation for Orthopaedics and Regenerative Medicine at 2 sites in 2 countries.
Trial summary
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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Cultured Allogeneic Adult Umbilical-cord or Placental Derived Mesenchymal Stem Cell Intrathecal injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Dec 2024to Dec 2028
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of Spinal Cord Injury
- Understanding and willingness to sign a written informed consent document
Who cannot join
- Active infection
- Active cancer
- Chronic multisystem organ failure
- Pregnancy
- Anticoagulation medicine use
- Clinically significant Abnormalities on pre-treatment laboratory evaluation
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- 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
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
Prodromos Stem Cell Institute
Naples, Florida, 34102
Chadwick Prodromos, MD, 847-699-6810 ext. 202, care@thepsci.com
Greece1 site, 1 recruiting
- Recruiting
Prodromos Stem Cell Institute
Athens
Chadwick Prodromos, MD, 847-699-6810 ext. 202, care@thepsci.com
About this study
Official title: Safety of Cultured Allogeneic Adult Umbilical-cord or Placental 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 allogeneic adult umbilical-cord or placental derived mesenchymal stem cells for the treatment of spinal cord injury
Read the 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 allogeneic adult umbilical-cord or placental derived mesenchymal stem cell 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.
- Conditions
- Spinal Cord Injuries
- Being tested
- Cultured Allogeneic Adult Umbilical-cord or Placental Derived Mesenchymal Stem Cell Intrathecal injection
- Keywords
- spinal cord injury, SCI, stem cell treatment
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cultured Allogeneic Adult Umbilical-cord or Placental Derived Mesenchymal Stem Cell Intrathecal injectionBiological
Cultured Allogeneic Adult Umbilical-cord or Placental Derived Mesenchymal Stem Cell Intrathecal injection
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Single intrathecal injection of 100 million cells Receives: Biological: Cultured Allogeneic Adult Umbilical-cord or Placental Derived Mesenchymal Stem Cell Intrathecal injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (adverse events)
Clinical monitoring of possible adverse events or complications
Measured: Four year follow-up
Secondary outcomes (1)
Efficacy: American Spinal Injury Association Impairment Scale (ASIA)
It will be completed for each follow up point
Measured: Four year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start1 Dec 2024
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Foundation for Orthopaedics and Regenerative Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chadwick Prodromos, MD, Principal investigator, The Foundation for Orthopaedics and Regenerative Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05018793
- Sponsor's protocol ID
- SC-8-GR-10-02
- Status last verified
- Oct 2026
- First submitted
- 19 Aug 2021
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 31785831Hur 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.
PubMed 26208177Roberts 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.
PubMed 27815685