RecruitingPhase 1NCT05016804

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

Sponsor

The Foundation for Orthopaedics and Regenerative Medicine

Enrollment

20 participants

Start Date

Jul 4, 2022

Study Type

INTERVENTIONAL

Conditions

Systemic Sclerosis

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

Eligibility

Inclusion Criteria2

Diagnosis of Systemic Sclerosis
Understanding and willingness to sign a written informed consent document

Exclusion Criteria10

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

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Interventions

BIOLOGICALAlloRx

cultured allogeneic adult umbilical cord derived mesenchymal stem cells

Locations(2)

Medical Surgical Associates Center

St John's, Antigua and Barbuda

Center for Investigation in Tissue Engineering and Cellular Therapy

Buenos Aires, Argentina

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NCT05016804

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