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

NCT01771679 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2022-10-31

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Stemedica Cell Technologies, Inc.

    lead INDUSTRY

Principal Investigators

  • Lev Verkh, PhD · Stemedica Cell Technologies, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-07-01
Primary Completion
2024-04-30
Completion
2024-12-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01771679 on ClinicalTrials.gov