Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for IBD
Phase 1 · Testing AlloRx · 2 sites · The Foundation for Orthopaedics and Regenerative Medicine
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing AlloRx (a biologic) as a possible treatment. Condition(s) listed: Inflammatory Bowel Diseases.
It is open-label: participants know what they are receiving.
Phase 1 studies are early tests in a small group of people, mainly checking safety and dosing.
Who can join
- Age range not stated in the record
- Any sex
Some of the main requirements, copied from the record:
- Diagnosis of Crohn's disease or Ulcerative Colitis
- Understanding and willingness to sign a written informed consent document
There are also 10 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 15 participants are expected to take part.
- Start date: 2022-06-11.
- Main results expected around 2025-10 (estimate from the record).
- 2 study sites listed (2 marked recruiting) in Antigua and Barbuda and Argentina.
Main thing being measured
- Safety (adverse events) (Four year follow-up)
In the researchers’ words
This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of inflammatory bowel disease
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 1 |
| Study type | Interventional |
| Conditions | Inflammatory Bowel Diseases |
| Lead sponsor | The Foundation for Orthopaedics and Regenerative Medicine |
| Enrollment | 15 (estimated) |
| Start date | 2022-06-11 |
| Primary completion (est.) | 2025-10 |
| First posted | 2021-08-13 |
| Last updated | 2025-04-10 |
| Official title | Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Inflammatory Bowel Disease |
| ClinicalTrials.gov ID | NCT05003947 |
Interventions
- AlloRx (Biological)
cultured allogeneic adult umbilical cord derived mesenchymal stem cells
Full eligibility criteria (from the record)
Inclusion Criteria: * Diagnosis of Crohn's disease or Ulcerative Colitis * Understanding and willingness to sign a written informed consent document Exclusion Criteria: * Active infection * Active cancer * Chronic multisystem organ failure * Pregnancy * Clinically significant Abnormalities on pre-treatment laboratory evaluation * Medical condition that would (based on the opinion of the investigator) compromise patient's safety. * Continued drug abuse * Pre-menopausal women not using contraception * Previous organ transplant * Hypersensitivity to sulfur
Locations (2)
| Site | City | Country | Site status |
|---|---|---|---|
| Medical Surgical Associates Center | St John's | Antigua and Barbuda | Recruiting |
| Center for Investigation in Tissue Engineering and Cellular Therapy | Buenos Aires | Argentina | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.