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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by Stemedica Cell Technologies, Inc.
Sponsor:
Collaborator:
StemCutis
Information provided by (Responsible Party):
Stemedica Cell Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT01771679
First received: January 16, 2013
Last updated: July 20, 2014
Last verified: July 2014
  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 chronic skin aging and photodamage on the face.


Condition Intervention Phase
Intrinsic Aging of Skin
Chronic Effect of Ultraviolet Radiation on Normal Skin (Photo-aging)
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, Multi-Center, 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

Resource links provided by NLM:


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, photographs and biopsies.


Secondary Outcome Measures:
  • MSC Safety and Tolerability [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    • VISIA-CR 2D photography
    • PRIMOS 3D assessment of lateral canthal rhytids and nasolabial folds
    • VECTRA 3D photography
    • punch biopsy from the lateral canthal area
    • Subject self-assessment
    • Independent evaluator assessment
    • Principle investigator assessment


Estimated Enrollment: 29
Study Start Date: June 2014
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part 1: Cohort 1
Allogeneic Mesenchymal Bone Marrow Cells (0.5, 1.0, or 1.5 million cells/kg)
Biological: Allogeneic Mesenchymal Bone Marrow Cells
Subjects in Part 1 will receive a single intravenous injection of 0.5, 1.0, or 1.5 million mesenchymal cells per kilogram body weight, not to exceed 150 million cells total. Subjects in part 2 will receive a single intravenous injection of mesenchymal cells at the Maximum Tolerated Dose, as determined by the safety results of Part 1.

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 photodamage.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria:

  • Females 40-70 years of age
  • Good general health
  • Fitzpatrick skin type I-III
  • Fitzpatrick cutaneous assessment of class III . Assess the periorbital area for fine to moderate lines and the nasolabial folds for deeper lines.
  • No substantial improvement in cutaneous photoaging for the 2 months prior to enrollment in the study per medical history.
  • 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 neoplasm within the past 5 years
  • Active cutaneous infection of the head and neck
  • Active cutaneous neoplasm in the treatment area
  • Topical retinoid use on the head and/or neck in the past 3 months
  • Cosmetic surgical treatment in the past 6 months (includes laser, chemical peels, fillers, botulinum toxin and other cutaneous surgery)
  • Positive for hepatitis B, C or HIV
  • Presence of any other clinically significant medical condition, or laboratory abnormality that in the judgment of the Investigator or Sponsor for which participation in the study would pose a safety risk to the subject
  • 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 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 or planning to become pregnant during the study
  • 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
Sharp Rees- Stealy Scripps Ranch Not yet recruiting
San Diego, California, United States, 92131
Contact: Dannielle Nichols, RN    858-621-4010    Dannielle.Nichols@sharp.com   
Principal Investigator: Curt M Littler, MD         
Sponsors and Collaborators
Stemedica Cell Technologies, Inc.
StemCutis
Investigators
Principal Investigator: Curt M Littler, MD Sharp Rees-Stealy Medical Group
  More Information

No publications provided

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 20, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Skin Diseases

ClinicalTrials.gov processed this record on July 26, 2014