NCT01771679

Safety Study of Bone Marrow Derived Stem Cells on Patients With Cutaneous Photoaging

A Phase I/II, Open-Label Study to Assess the Safety, Tolerability, and Preliminary Efficacy of a Single Intravenous Dose of Allogeneic Mesenchymal Bone Marrow Cells to Subjects for Cutaneous Photoaging

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 29 (estimated)
• Sponsor: Stemedica Cell Technologies, Inc. · Industry
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine whether a one-time injection of allogeneic mesenchymal bone marrow cells is safe and beneficial in the treatment of photodamage on the face.

Detailed description

Mesenchymal stem cells (MSCs) have been isolated from a number of sources, including bone marrow, adipose tissue, and peripheral blood. The MSCs manufactured for this study are a subset of non-hematopoietic stem cells derived from the bone marrow of healthy, adult donors. These cells have the ability to migrate to areas of injury in the body and can differentiate into multiple cell types, including cutaneous cells. In addition to contributing directly to repair of the skin by replacing damaged cells, MSCs also stimulate the body's own cells to regenerate. Though an increasing number of patients are seeking remedies for photoaged skin, current treatments, ranging from topical medications to laser peels, are not ideal methods for addressing the medical need. Because MSCs have been shown in clinical and non-clinical applications to be useful in wound healing, it is also possible that the cells will have a similar effect in skin rejuvenation. In the present study, we will determine the efficacy and safety of intravenously delivered MSCs in otherwise healthy patients with significant cutaneous photodamage.

Conditions

• Chronic Effect of Ultraviolet Radiation on Photoaged Skin
• Dermatologic Disorders

Interventions

Type	Name	Description
BIOLOGICAL	Allogeneic Mesenchymal Bone Marrow Cells	Subjects in Part 1, Cohorts 1-3 will receive a 1550 nm Fraxel laser (6-8 mJ, Level 2) treatment on the face followed by a single intravenous infusion of 0.5, 1.0, or 1.5 million mesenchymal cells per kg of body weight, not to exceed 150 million cells. Subjects in Part 2 will receive a 1550 Fraxel laser (6-8 mJ, Level 2) treatment on the face followed by a single intravenous infusion of mesenchymal cells at the Maximum Tolerated Dose, as determined by the safety results of Part 1. The dose in Part 2 is 1.5 million cells per kg, not to exceed a total of 150 million cells.

Timeline

• Start date: 2015-07-01
• Primary completion: 2024-04-30
• Completion: 2024-12-31
• First posted: 2013-01-18
• Last updated: 2022-10-31

Locations

2 sites across 1 country: United States