Treatment for hair loss and skin rejuvenation using fat-derived cells
Autologous Adipose Cells Therapy
This study is testing a new treatment using fat cells to see if it can help people with hair loss and improve their skin's appearance.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 21 Years to 80 Years |
| Sex | All |
| Sponsor | Cerm INC. Industry-sponsored |
| Locations | 2 sites (Lewes, Delaware and 1 other locations) |
| Trial ID | NCT06869252 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of Autologous Adipose Cell Therapy, which aims to improve skin rejuvenation and hair restoration by isolating early-stage adipose cells from lipoaspirate. The approach seeks to enhance traditional autologous fat grafting and dermal fillers by optimizing the number of adipocytes, potentially leading to longer-lasting aesthetic outcomes. Participants will undergo procedures designed to assess the feasibility of this innovative therapy in addressing conditions such as wrinkles, fine lines, and hair thinning.
Who should consider this trial
Good fit: Ideal candidates include adults aged 21 to 80 experiencing skin aging signs or hair loss.
Not a fit: Patients with chronic diseases, active infections, or a history of cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide patients with more effective and longer-lasting solutions for hair loss and skin rejuvenation.
How similar studies have performed: Other studies have shown promise with similar approaches in fat grafting and cell therapy, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Outpatients who express interest in skin rejuvenation, and/or who are experiencing skin conditions, such as winkles, fine lines, loss of skin elasticity, skin pigmentation, scarring. 2. Outpatients who are experiencing hair loss or hair thinning 3. Provision of signed and dated informed consent form 4. Clearly stated willingness to comply with all the procedures of the study and availability of the study 5. Female and Male aged between 21 to 80 years old 6 Medical clearance by family doctor Exclusion Criteria: 1. Pregnancy or lactation 2. Known allergic reaction to components of cell culture media 3. Chronic disease , e.g. cardiovascular disease, diabetes, chronic kidney disease, seizures 4. Chronic infections, e.g. skin fungi infection, psoriasis 5. Chronic wound healing 6. Currently taking hormone therapy 7. History of cancers and active cancers 8. Viral infection, e.g. HIV, hepatitis B, influenza, coronaviruses.
Where this trial is running
Lewes, Delaware and 1 other locations
- The Centre for Cosmetic Surgery & Medicine, Newark — Lewes, Delaware, United States (Recruiting)
- The Centre for Cosmetic Surgery & Medicine — Newark, Delaware, United States (Recruiting)
Study contacts
- Principal investigator: Dr. Abdollah M. Malekzadeh, MD, MD — The Centre for Cosmetic Surgery & Medicine
- Study coordinator: Ankeet Dixit
- Email: ankeetdixit@cermbio.com
- Phone: 813-992-2521
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.