Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell IV Infusion for Systemic Sclerosis

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Systemic Sclerosis

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05016804

Enrollment

Registered

2021-08-23

Start date

2022-07-04

Completion date

2026-11-30

Last updated

2025-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Sclerosis

Keywords

Systemic Sclerosis, Scleroderma, stem cell treatment

Brief 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 Systemic Sclerosis

Detailed description

Studies have shown that stem cell treatment is safe and efficacious for the treatment of Systemic Sclerosis. Patients with Systemic Sclerosis will receive a single intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells. 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 requiring chemotherapeutic drugs such as methotrexate, an autologous T Cell vaccine will be utilized created from the patient's own T cells obtained by apheresis.

Interventions

BIOLOGICALAlloRx

cultured allogeneic adult umbilical cord derived mesenchymal stem cells

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Diagnosis of Systemic Sclerosis * 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

Design outcomes

Primary

Measure	Time frame	Description
Safety (adverse events)	Four year follow-up	Clinical monitoring of possible adverse events or complications

Secondary

Measure	Time frame	Description
Efficacy: skin score	Four year follow-up	It will be completed for each follow up point.
Efficacy: Forced vital capacity (FVC)	Four year follow-up	It will be completed for each follow up point.

Countries

Antigua and Barbuda, Argentina

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026