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

Launched by THE FOUNDATION FOR ORTHOPAEDICS AND REGENERATIVE MEDICINE · Aug 17, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating the safety and effectiveness of a new treatment for Systemic Sclerosis, a condition that causes hardening and tightening of the skin and connective tissues. The treatment involves infusing stem cells derived from umbilical cords into the bloodstream. The researchers want to see if this approach can help patients with Systemic Sclerosis feel better and improve their health.

To participate in this trial, individuals must have a confirmed diagnosis of Systemic Sclerosis and be willing to sign a consent form that explains the study. However, some people cannot participate, such as those with active infections, cancer, certain serious health conditions, or who are pregnant. If someone joins the trial, they can expect to receive the stem cell infusion and be closely monitored for any side effects or improvements in their condition. This study is currently looking for participants of all genders and ages, as long as they meet the eligibility criteria.

Gender

ALL

Eligibility criteria

• 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