Chronic Effect of Ultraviolet Radiation on Photoaged SkinPhase 1/2NCT01771679
Safety Study of Bone Marrow Derived Stem Cells on Patients With Cutaneous Photoaging
A Phase 1/2 study testing Allogeneic Mesenchymal Bone Marrow Cells in people with Chronic Effect of Ultraviolet Radiation on Photoaged Skin and Dermatologic Disorders, run by Stemedica Cell Technologies, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Effect of Ultraviolet Radiation on Photoaged Skin, Dermatologic Disorders
- What is being tested?
- Allogeneic Mesenchymal Bone Marrow Cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2015to 31 Dec 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
eStudy Site
La Mesa, California, 91942
Naval Medical Center San Diego
San Diego, California, 92134
About this study
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
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.
Read the 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.
- Being tested
- Allogeneic Mesenchymal Bone Marrow Cells
- Keywords
- Mesenchymal Stem Cells, Bone Marrow Cells, Allogeneic Transplantation, Skin Wrinkling, Solar Aging of Skin, Intravenous Administration
- Medical subject headings
- Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic Mesenchymal Bone Marrow CellsBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Allogeneic Mesenchymal Bone Marrow Cells | Experimental | 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) Receives: Biological: Allogeneic Mesenchymal Bone Marrow Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 year
Secondary outcomes (1)
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)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2013 (estimated)
- Study start1 Jul 2015
- Primary completion30 Apr 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Effect of Ultraviolet Radiation on Photoaged SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stemedica Cell Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lev Verkh, PhD, Study director, Stemedica Cell Technologies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01771679
- Sponsor's protocol ID
- STEM 102-M
- Status last verified
- Oct 2020
- First submitted
- 16 Jan 2013
- Last updated
- 31 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01771679
- Acronym / sponsor ID
- STEM 102-M
- Keywords
- Mesenchymal Stem Cells, Bone Marrow Cells, Allogeneic Transplantation, Skin Wrinkling, Solar Aging of Skin, Intravenous Administration
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Stemedica Cell Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 18 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Allogeneic Mesenchymal Bone Marrow Cells | Experimental | Biological: Allogeneic Mesenchymal Bone Marrow Cells1550 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) |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allogeneic Mesenchymal Bone Marrow CellsSubjects 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. | Biological | Allogeneic Mesenchymal Bone Marrow Cells |
Primary outcome
MSC Safety and Tolerability
Time frame: 1 year
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 secondary outcome
MSC Efficacy
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lev Verkh, PhD study director
Stemedica Cell Technologies, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Allogeneic Mesenchymal Bone Marrow Cells in people with Chronic Effect of Ultraviolet Radiation on Photoaged Skin and Dermatologic Disorders, run by Stemedica Cell Technologies, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MSC Safety and Tolerability (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2022; AzTrials last refreshed its copy on 6 Nov 2026.