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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Dermatologic Disorders; Chronic Effect of Ultraviolet Radiation on Photoaged Skin
• Intervention / Treatment: Biological: Allogeneic Mesenchymal Bone Marrow Cells

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.

• Study Type: Interventional
• Enrollment (Anticipated): 29
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • La Mesa, California, United States, 91942
      • eStudy Site
    • San Diego, California, United States, 92134
      • Naval Medical Center San Diego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key Inclusion Criteria:

• Males and Females 40-70 years of age
• Good general health
• Fitzpatrick skin type I-III
• Fitzpatrick Wrinkle Scale class III. Fine to deep wrinkles, numerous lines with or without redundant skin folds
• Ability to understand and provide signed informed consent
• Reasonable expectation that subject will attend all scheduled safety follow-up visits
• Reasonable expectation that subject will maintain skin care regimen for the duration of the trial
• Adequate organ function

Key Exclusion Criteria:

• History of malignant neoplasm within the past 5 years, or Stage 3 or 4 of any cancer at any time
• History of melanoma, leukemia, or lymphoma (any stage)
• Persistent pre-cancerous lesions (e.g., actinic keratosis)
• Active cutaneous infection of the head and/or neck
• Active cutaneous neoplasm in the treatment area
• Topical use of any anti-aging creams on the head and/or neck; if used, subject must agree to discontinue for the one year of follow-up on study
• Cosmetic or surgical treatment on face/neck in 6 months before study (includes laser, chemical peels, fillers, botulinum toxin)
• Prior treatment with stem cells
• Positive for hepatitis B, C or HIV
• Abnormal and clinically significant findings on screening ECG
• Abnormal and clinically significant findings on screening CT scan of the chest (without contrast)
• Clinically significant medical condition for which participation in the study would pose a safety risk to the subject
• Major surgery within 4 weeks of Study Day 1
• Participation in another study with an investigational drug or device within 3 months prior to stem cell administration
• Participation in another study concurrent with the one-year duration of the trial
• History within the past year of drug or alcohol abuse
• Females known to be pregnant, lactating or having a positive pregnancy test (will be tested during screening) or planning to become pregnant during the study
• Sexually active males and females of child-bearing potential must use an effective method of birth control for duration of the study (approximately 13 months from the screening visit)
• Allergies to bovine and porcine products

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Allogeneic Mesenchymal Bone Marrow Cells; 1550 nm Fraxel laser treatment (6-8 mJ, Level 2) to full face followed by IV infusion of Allogeneic Mesenchymal Bone Marrow Cells (0.5, 1.0, or 1.5 million cells/kg, up to 150 million cells)

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MSC Safety and Tolerability	The primary endpoint will be the safety and tolerability of IV administration of allogeneic mesenchymal bone marrow cells (aMBMC) during the twelve month study period as determined by the incidence and severity of adverse events, clinically significant changes on clinical laboratory tests, vital signs, physical and cutaneous examinations, 12 lead ECGs and CT scans of the chest (without contrast)	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MSC Efficacy	VISIA-CR 2D photography; PRIMOS 3D images of face and neck; VECTRA 3D photography; Punch biopsy from the lateral canthal area to examine changes in decorin, fibrillin, elastin, MMPI, and procollagen-1; Subject self-assessment; Independent evaluator assessment; Principal investigator assessment; Changes in RNA sequencing (from blood specimens); Changes in MMP-1, Ang-2, VEGF and FGF (from blood specimens)	12 months

Collaborators and Investigators

• Sponsor: Stemedica Cell Technologies, Inc.
• Investigators: Study Director: Lev Verkh, PhD, Stemedica Cell Technologies, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Anticipated): April 30, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: January 16, 2013
• First Submitted That Met QC Criteria: January 16, 2013
• First Posted (Estimate): January 18, 2013

Study Record Updates

• Last Update Posted (Actual): October 31, 2022
• Last Update Submitted That Met QC Criteria: October 27, 2022
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Mesenchymal Stem Cells; Allogeneic Transplantation; Bone Marrow Cells; Skin Wrinkling; Solar Aging of Skin; Intravenous Administration
• Additional Relevant MeSH Terms: Skin Diseases
• Other Study ID Numbers: STEM 102-M

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No