Trial record 10 of 10 for:
Open Studies | "Skin Aging"
Safety Study of Bone Marrow Derived Stem Cells on Patients With Cutaneous Photoaging
This study is not yet open for participant recruitment.
Verified January 2013 by Stemedica Cell Technologies, Inc.
Sponsor:
Stemedica Cell Technologies, Inc.
Information provided by (Responsible Party):
Stemedica Cell Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT01771679
First received: January 16, 2013
Last updated: January 18, 2013
Last verified: January 2013
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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: | March 2013 |
| 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
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.
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: | January 18, 2013 |
| 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 June 17, 2013