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

Launched by THE FOUNDATION FOR ORTHOPAEDICS AND REGENERATIVE MEDICINE · Nov 16, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring the safety and effectiveness of a special type of stem cell treatment for women with Polycystic Ovary Syndrome (PCOS). PCOS is a condition that affects how a woman’s ovaries work and can lead to various health issues. The treatment involves using mesenchymal stem cells, which are derived from umbilical cord tissue, and these will be given through an intravenous (IV) infusion. The trial is currently recruiting female participants aged 18 to 45 who have been diagnosed with PCOS as confirmed by ultrasound.

To participate, women must not have certain health conditions, such as active infections, cancer, or serious organ problems, and they should not be pregnant or have had previous organ transplants. Participants can expect to receive the stem cell treatment and will be monitored for safety throughout the study. This trial is an important step in understanding how this new treatment might help manage PCOS and improve the quality of life for those affected by it.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • • Ultrasound documented poly cystic ovary syndrome
• 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
• • Previous organ transplant
• • Hypersensitivity to sulfur
• • Inability to supply proper informed consent