Bone Marrow Derived Stem Cells for Skin Aging

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and benefits of a one-time injection of special stem cells from bone marrow (allogeneic mesenchymal bone marrow cells) to treat sun-damaged facial skin. The treatment includes a specific laser procedure followed by an infusion of these cells to assess their potential in improving skin appearance. Individuals with fair to medium skin tone and noticeable wrinkles, who have not recently undergone facial cosmetic treatments, might be suitable candidates. The trial aims to assist those seeking new methods to address signs of aging caused by sun exposure. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. However, you must stop using any anti-aging creams on your head or neck for the duration of the study.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that certain stem cells, such as those from bone marrow, are gaining popularity in medicine for their healing abilities. These cells can renew themselves and may repair damaged areas. Studies have found that these stem cells are generally safe, with most individuals experiencing only mild side effects, if any.

However, some research highlights concerns. In rare cases, these stem cells have changed in lab settings and caused issues. This phenomenon has not been commonly observed in people, but researchers continue to monitor it closely.

Overall, these stem cells have been extensively studied and appear promising with a good safety record. However, like any treatment, there are risks to consider. Always consult a healthcare provider if there are concerns. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike standard treatments for skin aging, which often include topical creams, retinoids, and laser therapies, this innovative approach uses allogeneic mesenchymal bone marrow cells. Researchers are excited because these stem cells have the potential to rejuvenate skin by promoting tissue repair and regeneration at a cellular level, something current treatments can't achieve. This method combines a Fraxel laser treatment with an IV infusion of bone marrow cells, offering a dual approach that targets both surface and deeper skin layers for potentially more comprehensive anti-aging effects.

What evidence suggests that this treatment might be an effective treatment for skin aging?

Research has shown that certain stem cells from bone marrow may help treat skin problems. Studies have found that these cells can heal wounds and improve skin health. This trial will investigate the use of Allogeneic Mesenchymal Bone Marrow Cells, administered to participants after a 1550 nm Fraxel laser treatment. Evidence from trials suggests that injecting these cells can enhance skin health. Although more research is needed, early results are promising for using these cells to combat signs of aging skin. ^{1 3 5 6 7}

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3188697/

Potential benefits of allogeneic bone marrow mesenchymal ... Transplanted mesenchymal stem cells are effective for skin regeneration in acute cutaneous wounds. Cell Transplant. 2004;13(4):405–12. doi: 10.3727 ...

2. nature.com nature.com/articles/s41392-025-02313-9

Mesenchymal stem cells in treating human diseases Mesenchymal stem cells (MSCs) have emerged as a highly promising strategy in regenerative medicine due to their self-renewal, ...

3. stemcellres.biomedcentral.com stemcellres.biomedcentral.com/articles/10.1186/s13287-025-04318-1

Advances in mesenchymal stem cell and exosome-based ... Skin aging is one of the most intuitive manifestations of aging, and in skin aging research, MSCs have been found to be effective in combating ...

4. frontiersin.org frontiersin.org/journals/aging/articles/10.3389/fragi.2025.1638168/pdf

Recent progress in stem cell and immune ... Clinical trial data of stem cells against aging have demonstrated that intravenous injection of allogeneic mesenchymal stem cells can improve ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT01771679

Safety Study of Bone Marrow Derived Stem Cells on ... 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9659480/

Adverse events, side effects and complications in ... Long-term cultures of bone marrow-derived human mesenchymal stem cells frequently undergo spontaneous malignant transformation. Cancer Res 2009;69:5331-9 ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S053155652500110X

Mesenchymal stem cells and exosomes - ScienceDirect.com This review comprehensively explores the impact of MSCs and their Exos on key hallmarks of aging, including genomic instability, telomere attrition, epigenetic ...