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TerminatedNCT05147766Updated Apr 6, 2025

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for Heart Disease

A Phase 1 interventional study of AlloRx in Congestive Heart Failure and Angina, sponsored by The Foundation for Orthopaedics and Regenerative Medicine. Terminated at 2 sites in 2 countries. Per ClinicalTrials.gov, last updated 2025-04-06.

Sponsored by The Foundation for Orthopaedics and Regenerative Medicine · Phase 1, Interventional, and Treatment

Why this study was terminated
Insufficient efficacy seen in treated patients

From the registry’s dates

  • Primary completion was Apr 2025, 1 year 6 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
3
Allocation
Not applicable
Sex
All
01

Study summary

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 congestive heart failure and angina

Read the detailed description

This patient funded trial aims to study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of congestive heart failure and angina. Patients will receive a single intravenous infusion of UC-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.

For patients with more severe disease an autologous Effector cells (activated lymphocytes) treatment will be utilized created from the patient's own cells obtained by apheresis.

02

Conditions studied

  • Congestive Heart Failure
  • Angina

Keywords

  • Angina
  • Congestive Heart Failure
  • stem cell treatment
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 3 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

The Foundation for Orthopaedics and Regenerative Medicine is the lead sponsor of 33 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosis of Congestive Heart Failure or Angina
  • Understanding and willingness to sign a written informed consent document

Exclusion criteria

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
3 participants (actual)

Study arms

  • Experimental
    Treatment Group (AlloRx)

    Single intravenous infusion of 100 million cells

    Biological: AlloRx

Interventions

  • BiologicalAlloRx

    cultured allogeneic adult umbilical cord derived mesenchymal stem cells

06

What researchers measure

Primary outcomes

  1. Safety (adverse events)

    Clinical monitoring of possible adverse events or complications

    Time frame: Four year follow-up

07

Study locations

2 sites
  • Medical Surgical Associates Center
    St. John's, Antigua and Barbuda
  • Center for Investigation in Tissue Engineering and Cellular Therapy
    Buenos Aires, Argentina
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05147766
Lead sponsor
The Foundation for Orthopaedics and Regenerative Medicine
Responsible party
Sponsor
First posted
Dec 7, 2021
Start date
Feb 1, 2022
Primary completion
Apr 3, 2025
Completion
Apr 3, 2025
Last update
Apr 6, 2025

Study contacts

Chadwick Prodromos, MD
principal investigator · The Foundation for Orthopaedics and Regenerative Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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