Bone Marrow Derived Stem Cells for Skin Aging

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Stemedica Cell Technologies, Inc.

Must not be taking: Anti-aging creams

Disqualifiers: Cancer, Melanoma, Infections, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

29 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Lev Verkh, PhD

Principal Investigator

Stemedica Cell Technologies, Inc.

Are You a Good Fit for This Trial?

This trial is for men and women aged 40-70 with moderate to deep wrinkles, who are in good health and have a skin type I-III. They must not have had facial cosmetic treatments or cancer within the past 5 years, no stem cell treatments before, and can't be using anti-aging creams during the study.

Inclusion Criteria

Good general health

Reasonable expectation that subject will attend all scheduled safety follow-up visits

Fitzpatrick Wrinkle Scale class III. Fine to deep wrinkles, numerous lines with or without redundant skin folds

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intravenous dose of allogeneic mesenchymal bone marrow cells following Fraxel laser treatment

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments through photography, biopsies, and various evaluations

12 months

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Allogeneic Mesenchymal Bone Marrow Cells

Trial Overview The study tests if a one-time injection of allogeneic mesenchymal bone marrow cells is safe and effective for treating signs of aging on the face caused by sun exposure.

How Is the Trial Designed?

Group I: Allogeneic Mesenchymal Bone Marrow Cells Experimental Treatment 1 Intervention

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)

Who Is Running the Clinical Trial?

Stemedica Cell Technologies, Inc.

Lead Sponsor

Trials

6

Recruited

170+