Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Stemedica Cell Technologies, Inc.
Sponsor:
Collaborator:
StemCutis, LLC - A Stemedica Company
Information provided by (Responsible Party):
Stemedica Cell Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT01771679
First received: January 16, 2013
Last updated: July 28, 2016
Last verified: July 2016
  Purpose
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.

Condition Intervention Phase
Chronic Effect of Ultraviolet Radiation on Photoaged Skin
Dermatologic Disorders
Biological: Allogeneic Mesenchymal Bone Marrow Cells
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Stemedica Cell Technologies, Inc.:

Primary Outcome Measures:
  • MSC Safety and Tolerability [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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)


Secondary Outcome Measures:
  • MSC Efficacy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    • 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)


Estimated Enrollment: 29
Study Start Date: July 2015
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01771679

Locations
United States, California
eStudy Site Recruiting
La Mesa, California, United States, 91942
Contact: Whitley Harbison    619-567-1550    wharbison@estudysite.com   
Contact: Kayla Edge    619-5671550    kedge@estudysite.com   
Principal Investigator: Curt M Littler, MD         
Naval Medical Center San Diego Recruiting
San Diego, California, United States, 92134
Contact: John Paul Trafeli, MD    619-532-9660      
Principal Investigator: John Paul Trafeli, MD         
Sponsors and Collaborators
Stemedica Cell Technologies, Inc.
StemCutis, LLC - A Stemedica Company
  More Information

Responsible Party: Stemedica Cell Technologies, Inc.
ClinicalTrials.gov Identifier: NCT01771679     History of Changes
Other Study ID Numbers: STEM 102-M 
Study First Received: January 16, 2013
Last Updated: July 28, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Stemedica Cell Technologies, Inc.:
Mesenchymal Stem Cells
Bone Marrow Cells
Allogeneic Transplantation
Skin Wrinkling
Solar Aging of Skin
Intravenous Administration

Additional relevant MeSH terms:
Skin Diseases

ClinicalTrials.gov processed this record on September 23, 2016