NCT03059355

Infusion of Umbilical Cord Versus Bone Marrow Derived Mesenchymal Stem Cells to Evaluate Cytokine Suppression.

A Phase I/II, Randomized, Placebo-controlled Comparative Study to Evaluate the Safety and Potential Efficacy of Intravenous Infusion of Umbilical Cord Tissue (UC) Derived Mesenchymal Stem Cells (MSCs) Versus Bone Marrow (BM) Derived MSCs to Evaluate Cytokine Suppression in Patients With Chronic Inflammation Due to Metabolic Syndrome.

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Joshua M Hare · Academic / Other
• Sex: All
• Age: 21 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

This study is to compare the safety and efficacy of UCMSCs and BMMSCs administered intravenously in patients to evaluate cytokine suppression in patients with chronic inflammation. Cells administered via intravenous infusion (IV) and will be tested in 37 patients in two phases (Pilot and Randomized).

Conditions

• Endothelial Dysfunction
• Metabolic Syndrome
• Chronic Inflammation

Interventions

Type	Name	Description
BIOLOGICAL	UCMSCs	Allogeneic Umbilical Cord Tissue derived MSCs (UCMSCs)
BIOLOGICAL	BMMSCs	Bone Marrow derived Mesenchymal Stem Cells (BMMSCs)
OTHER	Placebo	a single administration of placebo delivered via peripheral intravenous infusion.

Timeline

• Start date: 2018-04-12
• Primary completion: 2020-03-23
• Completion: 2021-02-11
• First posted: 2017-02-23
• Last updated: 2022-11-08
• Results posted: 2022-11-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study