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Stem Cell Therapy

Bone Marrow Derived Stem Cells for Skin Aging

Phase 1 & 2

Waitlist Available

Research Sponsored by Stemedica Cell Technologies, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Males and Females 40-70 years of age

Be older than 18 years old

Must not have

History of melanoma, leukemia, or lymphoma (any stage)

Persistent pre-cancerous lesions (e.g., actinic keratosis)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trialexplores if an injection of bone marrow cells can help heal facial skin damaged by sunlight.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include reactions at the injection site, such as redness or swelling. Since it's a safety study, other unexpected side effects related to immune response might also be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 40 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of melanoma, leukemia, or lymphoma.

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I have ongoing skin conditions that could turn into cancer.

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I have a skin infection on my head or neck.

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I have not had cancer or been in late-stage cancer in the last 5 years.

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I have previously received stem cell treatment.

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My recent chest CT scan showed abnormal findings.

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I haven't had any cosmetic or surgical treatments on my face/neck in the last 6 months.

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I am not pregnant, breastfeeding, or planning to become pregnant during the study.

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I have not had major surgery in the last 4 weeks.

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I have a skin cancer in the area that would be treated.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

MSC Safety and Tolerability

Secondary study objectives

MSC Efficacy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Allogeneic Mesenchymal Bone Marrow CellsExperimental Treatment1 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)

0 / 11Eligibility criteria met