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

Phase 1RecruitingNCT05016804

The Foundation for Orthopaedics and Regenerative Medicine20 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Systemic Sclerosis

Interventions

AlloRxBIOLOGICAL

cultured allogeneic adult umbilical cord derived mesenchymal stem cells

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (2)

Medical Surgical Associates Center

St John's, Antigua and Barbuda

RECRUITING

Center for Investigation in Tissue Engineering and Cellular Therapy

Buenos Aires, Argentina

RECRUITING

Outcomes

Primary Outcomes

Safety (adverse events)

Clinical monitoring of possible adverse events or complications

Time frame: Four year follow-up

Secondary Outcomes

Efficacy: skin score

It will be completed for each follow up point.

Time frame: Four year follow-up

Efficacy: Forced vital capacity (FVC)

It will be completed for each follow up point.

Time frame: Four year follow-up

Data from ClinicalTrials.gov

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