Safety Study of Bone Marrow Derived Stem Cells on Patients With Cutaneous Photoaging
Primary Purpose
Chronic Effect of Ultraviolet Radiation on Photoaged Skin, Dermatologic Disorders
Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Allogeneic Mesenchymal Bone Marrow Cells
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Effect of Ultraviolet Radiation on Photoaged Skin focused on measuring Mesenchymal Stem Cells, Bone Marrow Cells, Allogeneic Transplantation, Skin Wrinkling, Solar Aging of Skin, Intravenous Administration
Eligibility 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
Sites / Locations
- eStudy Site
- Naval Medical Center San Diego
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Allogeneic Mesenchymal Bone Marrow Cells
Arm Description
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)
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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)
Full Information
NCT ID
NCT01771679
First Posted
January 16, 2013
Last Updated
October 27, 2022
Sponsor
Stemedica Cell Technologies, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01771679
Brief Title
Safety Study of Bone Marrow Derived Stem Cells on Patients With Cutaneous Photoaging
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 1, 2015 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stemedica Cell Technologies, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Effect of Ultraviolet Radiation on Photoaged Skin, Dermatologic Disorders
Keywords
Mesenchymal Stem Cells, Bone Marrow Cells, Allogeneic Transplantation, Skin Wrinkling, Solar Aging of Skin, Intravenous Administration
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Allogeneic Mesenchymal Bone Marrow Cells
Arm Type
Experimental
Arm Description
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)
Intervention Type
Biological
Intervention Name(s)
Allogeneic Mesenchymal Bone Marrow Cells
Intervention Description
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.
Primary Outcome Measure Information:
Title
MSC Safety and Tolerability
Description
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)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
MSC Efficacy
Description
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)
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lev Verkh, PhD
Organizational Affiliation
Stemedica Cell Technologies, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
eStudy Site
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Naval Medical Center San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92134
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety Study of Bone Marrow Derived Stem Cells on Patients With Cutaneous Photoaging
We'll reach out to this number within 24 hrs