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

NCT01771679 | Unknown Phase 1 DMC

• 1 other identifier: STEM 102-M
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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)

  1 year

Secondary Outcomes (1)

• MSC Efficacy

  12 months

Study Arms (1)

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)

Biological: Allogeneic Mesenchymal Bone Marrow Cells

Interventions

Allogeneic Mesenchymal Bone Marrow Cells BIOLOGICAL

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.

Allogeneic Mesenchymal Bone Marrow Cells

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stemedica Cell Technologies, Inc.: lead

Study Sites (2)

eStudy Site

La Mesa, California, 91942, United States

Location

Naval Medical Center San Diego

San Diego, California, 92134, United States

Location

MeSH Terms

Conditions

Skin Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Study Officials

• Lev Verkh, PhD

  Stemedica Cell Technologies, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2013
• First Posted: January 18, 2013
• Study Start: July 1, 2015
• Primary Completion: April 30, 2024
• Study Completion: December 31, 2024
• Last Updated: October 31, 2022

Record last verified: 2020-10

Locations

US (2)