Hair Loss/BaldnessPhase 1/2NCT06869252
Autologous Adipose Cells Therapy
A Phase 1/2 study testing Autologous Adipose Cells Therapy in people with Hair Loss/Baldness and Wrinkle Appearance, run by CERM INC. at 2 sites in United States.
Trial summary
Autologous Adipose Cell Therapy is a series of process designated to address the demerits of the traditional autologous fat grafting and dermal fillers, while enhancing the versatility and aesthetic outcomes. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Hair Loss/Baldness, Wrinkle Appearance, Volume
- What is being tested?
- Autologous Adipose Cells Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2025to 1 Feb 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Outpatients who are experiencing hair loss or hair thinning
- Provision of signed and dated informed consent form
- Clearly stated willingness to comply with all the procedures of the study and availability of the study
- Female and Male aged between 21 to 80 years old 6 Medical clearance by family doctor
Who cannot join
- Pregnancy or lactation
- Known allergic reaction to components of cell culture media
- Chronic disease , e.g. cardiovascular disease, diabetes, chronic kidney disease, seizures
- Chronic infections, e.g. skin fungi infection, psoriasis
- Chronic wound healing
- Currently taking hormone therapy
- History of cancers and active cancers
- Viral infection, e.g. HIV, hepatitis B, influenza, coronaviruses.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
The Centre for Cosmetic Surgery & Medicine, Newark
Lewes, Delaware, 19958
Dr. Abdollah M. Malekzadeh, MD, 302-645-7672, lewes@thecentreforcosmeticsurgery.com
abdol@comcast.com
- Recruiting
The Centre for Cosmetic Surgery & Medicine
Newark, Delaware, 19713
Dr. Abdollah M. Malekzadeh, MD, 302-994-8492, lewes@thecentreforcosmeticsurgery.com
abdol@comcast.com
About this study
Autologous Adipose Cell Therapy is a series of process designated to address the demerits of the traditional autologous fat grafting and dermal fillers, while enhancing the versatility and aesthetic outcomes. In this study, the goal is to evaluate the safety and efficacy of Autologous Adipose cell Therapy for skin rejuvenation and hair improvement in human application.
Read the detailed description
Autologous fat grafting (AFG) and injection of dermal fillers are the most prevailing aesthetic procedures in the cosmetic field for skin rejuvenation and hair restoration. High degree of biocompatibility and biodegradability of dermal fillers contribute significantly to their effectiveness in skin rejuvenation and hair restoration; however, the results are typically not enduring. On the other hand, autologous fat grafting is increasingly recognized for its applications not only in skin rejuvenation, but also breast augmentation and the treatment of arthritis. Fat fillers are fully biocompatible to the recipient, due to the use of autologous cell, the effects generally persist longer than those achieved with dermal fillers. Nonetheless, unprocessed lipoaspirate collected through liposuction procedure has a heterogeneous composition, which potentially leads to uneven distribution of adipose tissu resulting in formation of lumps or nodules at the recipient's site. Volume retention following autologous fat grafting is not solely affected by the resorption rate of adipose cells, but also impacted by re-uptake rate of other components of lipoaspirate. Autologous Adipose Cell Therapy seeks to enhance the current autologous fat grafting by isolating early-stage adipose cells from lipoaspirate and optimizing the number of adipocytes cells within the fat filler through cell property of differentiation. The purpose of this study is to assess the safety, feasibility, and efficacy of Autologous Adipose Cell Therapy for skin rejuvenation and hair improvement in human subjects. The eligibility of participants who are interested in participating in this study will be determined based on the inclusion and exclusion criteria listed in the study protocol. The in-charge plastic surgeon will monitor and evaluate the treatment outcomes in participants over a six-months period after the administration of Autologous Adipose Cell Therapy.
- Conditions
- Hair Loss/Baldness, Wrinkle Appearance, Volume, Fine Lines, Skin Elasticity, Hair Thinning
- Being tested
- Autologous Adipose Cells Therapy
- Keywords
- Adipose Cells, Adipocytes
- Medical subject headings
- Alopecia, Pigmentation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Adipose Cells TherapyBiological
Participants will receive Autologous Adipose Cells therapy treatment, and the safety and efficacy of the treatment will be monitored by the primary investigator up to 25 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Autologous Adipose Cells Therapy | Experimental | Not described Receives: Biological: Autologous Adipose Cells Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome Comparison Survey
30 people will be randomly selected to rank the level of improvement by comparing the images captured at pro and post-treatment from Imaging assessment.
Scale of Improvement:
- No Improvement(0%)
- Minimal Improvement(1% - 25%)
- Moderate Improvement(26% - 50%)
- Significant Improvement(51% - 75%)
- Major Improvement(76% - 100%)
Measured: The end of the study (Week 20 to 25)
Participant Satisfaction Survey
Participants will be requested to complete a list of questions related to their experience and satisfaction of autologous adipose cell therapy in each study visit for result evaluation.
1-to-5 Scales:
- 1 being "very poor" and 5 being "excellent"
- 1 being "very dissatisfied" and 5 being "very satisfied"
Measured: From first post-treatment follow-up visit to the last follow-up visit at week 16 to week 25
Imaging Assessment
Digital images of the target site will be captured for each participant both prior to and following autologous adipose cell therapy for the purpose of outcome evaluation. The comparison of pre- and post-treatment images will be utilized in the "Outcome Comparison Survey" and the "Visit Evaluation Report" to assess the degree of improvement, based on the established assessment parameters for Autologous Adipose Cell Therapy treatment.
Measured: From first pre-treatment visit to the last follow-up visit at week 16 to week 25
Case Report Form
A comprehensive medical document will be prepared by the responsible plastic surgeon which outlines the key details of each stage of the treatment process and aspects based on each participant's case. This document will include a thorough description of the patient's presenting medical conditions, the surgical procedures performed, post-treatment progress, any adverse events that occurred, and the final outcomes.
Measured: The report will be completed at the end of the study (Week 20 to 25), but highlights would be recorded in this document during every visit.
Visit Evaluation Report
During each post-treatment visit, the responsible plastic surgeon will assess the treatment outcomes and evaluate the degree of improvement by comparing the pre-treatment image with the current post-treatment image.
Scale of Improvement:
- No Improvement(0%)
- Minimal Improvement(1% - 25%)
- Moderate Improvement(26% - 50%)
- Significant Improvement(51% - 75%)
- Major Improvement(76% - 100%)
Assessment Parameters:
Skin:
- Radiance
- Texture
- Firmness
- Wrinkles \& Fine Lines
- Spot Hyperpigmentation
- Tone
- Redness \& Inflammation
- Pore Size
Hair:
- Density
- Thickness
- Visual Appearance
- Texture (Smoothness \& Frizz Control)
- Shine
- Scalp Health
Measured: From first post-treatment follow-up visit to the last follow-up visit at week 16 to week 25
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hair Loss/BaldnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CERM INC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Abdollah M. Malekzadeh, MD, MD, Principal investigator, The Centre for Cosmetic Surgery & MedicineDr. Arun Kumar, PhD, Study director, CERM INC.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06869252
- Sponsor's protocol ID
- CERM 002
- Status last verified
- May 2025
- First submitted
- 27 Feb 2025
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bellini E, Grieco MP, Raposio E. The science behind autologous fat grafting. Ann Med Surg (Lond). 2017 Nov 10;24:65-73. doi: 10.1016/j.amsu.2017.11.001. eCollection 2017 Dec.
PubMed 29188051Sutcliffe H, Rawlinson PS, Thakker B, Neary R, Mallick N. Factitious proteinuria: diagnosis and protein identification by use of isoelectric focusing. Clin Chem. 1988 Aug;34(8):1653-5.
PubMed 3402073An Y, Wang G, Li X, Zhen Y, Zhao J, Li D. Rhinoplasty with Simultaneous Autologous Full-Face Fat Transfer for Asian Facial Contouring Balance: A Retrospective Study. Aesthetic Plast Surg. 2023 Apr;47(2):746-756. doi: 10.1007/s00266-022-03064-6. Epub 2022 Aug 30.
PubMed 36042025
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Adipose Cells Therapy
- ClinicalTrials.gov ID
- NCT06869252
- Acronym / sponsor ID
- CERM 002
- Conditions
- Hair Loss/Baldness, Wrinkle Appearance, Volume, Fine Lines, Skin Elasticity, Hair Thinning
- Keywords
- Adipose Cells, Adipocytes
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- CERM INC.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Autologous Adipose Cell Therapy is a series of process designated to address the demerits of the traditional autologous fat grafting and dermal fillers, while enhancing the versatility and aesthetic outcomes. In this study, the goal is to evaluate the safety and efficacy of Autologous Adipose cell Therapy for skin rejuvenation and hair improvement in human application.
Detailed description
Autologous fat grafting (AFG) and injection of dermal fillers are the most prevailing aesthetic procedures in the cosmetic field for skin rejuvenation and hair restoration. High degree of biocompatibility and biodegradability of dermal fillers contribute significantly to their effectiveness in skin rejuvenation and hair restoration; however, the results are typically not enduring. On the other hand, autologous fat grafting is increasingly recognized for its applications not only in skin rejuvenation, but also breast augmentation and the treatment of arthritis. Fat fillers are fully biocompatible to the recipient, due to the use of autologous cell, the effects generally persist longer than those achieved with dermal fillers. Nonetheless, unprocessed lipoaspirate collected through liposuction procedure has a heterogeneous composition, which potentially leads to uneven distribution of adipose tissu resulting in formation of lumps or nodules at the recipient's site. Volume retention following autologous fat grafting is not solely affected by the resorption rate of adipose cells, but also impacted by re-uptake rate of other components of lipoaspirate. Autologous Adipose Cell Therapy seeks to enhance the current autologous fat grafting by isolating early-stage adipose cells from lipoaspirate and optimizing the number of adipocytes cells within the fat filler through cell property of differentiation. The purpose of this study is to assess the safety, feasibility, and efficacy of Autologous Adipose Cell Therapy for skin rejuvenation and hair improvement in human subjects. The eligibility of participants who are interested in participating in this study will be determined based on the inclusion and exclusion criteria listed in the study protocol. The in-charge plastic surgeon will monitor and evaluate the treatment outcomes in participants over a six-months period after the administration of Autologous Adipose Cell Therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous Adipose Cells Therapy | Experimental | Biological: Autologous Adipose Cells Therapy |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- Outpatients who are experiencing hair loss or hair thinning
- Provision of signed and dated informed consent form
- Clearly stated willingness to comply with all the procedures of the study and availability of the study
- Female and Male aged between 21 to 80 years old 6 Medical clearance by family doctor
Key exclusion criteria (8 listed)
- Pregnancy or lactation
- Known allergic reaction to components of cell culture media
- Chronic disease , e.g. cardiovascular disease, diabetes, chronic kidney disease, seizures
- Chronic infections, e.g. skin fungi infection, psoriasis
- Chronic wound healing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Adipose Cells TherapyParticipants will receive Autologous Adipose Cells therapy treatment, and the safety and efficacy of the treatment will be monitored by the primary investigator up to 25 weeks. | Biological | Autologous Adipose Cells Therapy |
Primary outcome
Outcome Comparison Survey
Time frame: The end of the study (Week 20 to 25)
30 people will be randomly selected to rank the level of improvement by comparing the images captured at pro and post-treatment from Imaging assessment. Scale of Improvement: * No Improvement(0%) * Minimal Improvement(1% - 25%) * Moderate Improvement(26% - 50%) * Significant Improvement(51% - 75%) * Major Improvement(76% - 100%)
Participant Satisfaction Survey
Time frame: From first post-treatment follow-up visit to the last follow-up visit at week 16 to week 25
Participants will be requested to complete a list of questions related to their experience and satisfaction of autologous adipose cell therapy in each study visit for result evaluation. 1-to-5 Scales: * 1 being "very poor" and 5 being "excellent" * 1 being "very dissatisfied" and 5 being "very satisfied"
Imaging Assessment
Time frame: From first pre-treatment visit to the last follow-up visit at week 16 to week 25
Digital images of the target site will be captured for each participant both prior to and following autologous adipose cell therapy for the purpose of outcome evaluation. The comparison of pre- and post-treatment images will be utilized in the "Outcome Comparison Survey" and the "Visit Evaluation Report" to assess the degree of improvement, based on the established assessment parameters for Autologous Adipose Cell Therapy treatment.
Case Report Form
Time frame: The report will be completed at the end of the study (Week 20 to 25), but highlights would be recorded in this document during every visit.
A comprehensive medical document will be prepared by the responsible plastic surgeon which outlines the key details of each stage of the treatment process and aspects based on each participant's case. This document will include a thorough description of the patient's presenting medical conditions, the surgical procedures performed, post-treatment progress, any adverse events that occurred, and the final outcomes.
Visit Evaluation Report
Time frame: From first post-treatment follow-up visit to the last follow-up visit at week 16 to week 25
During each post-treatment visit, the responsible plastic surgeon will assess the treatment outcomes and evaluate the degree of improvement by comparing the pre-treatment image with the current post-treatment image. Scale of Improvement: * No Improvement(0%) * Minimal Improvement(1% - 25%) * Moderate Improvement(26% - 50%) * Significant Improvement(51% - 75%) * Major Improvement(76% - 100%) Assessment Parameters: Skin: * Radiance * Texture * Firmness * Wrinkles \& Fine Lines * Spot Hyperpigmentation * Tone * Redness \& Inflammation * Pore Size Hair: * Density * Thickness * Visual Appearance * Texture (Smoothness \& Frizz Control) * Shine * Scalp Health
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Background: PubMed 29188051Bellini E, Grieco MP, Raposio E. The science behind autologous fat grafting. Ann Med Surg (Lond). 2017 Nov 10;24:65-73. doi: 10.1016/j.amsu.2017.11.001. eCollection 2017 Dec.
- Background: PubMed 3402073Sutcliffe H, Rawlinson PS, Thakker B, Neary R, Mallick N. Factitious proteinuria: diagnosis and protein identification by use of isoelectric focusing. Clin Chem. 1988 Aug;34(8):1653-5.
- Background: PubMed 36042025An Y, Wang G, Li X, Zhen Y, Zhao J, Li D. Rhinoplasty with Simultaneous Autologous Full-Face Fat Transfer for Asian Facial Contouring Balance: A Retrospective Study. Aesthetic Plast Surg. 2023 Apr;47(2):746-756. doi: 10.1007/s00266-022-03064-6. Epub 2022 Aug 30.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. Abdollah M. Malekzadeh, MD, MD principal investigator
The Centre for Cosmetic Surgery & Medicine
Dr. Arun Kumar, PhD study director
CERM INC.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Autologous Adipose Cells Therapy in people with Hair Loss/Baldness and Wrinkle Appearance, run by CERM INC. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ankeet Dixit (813-992-2521, ankeetdixit@cermbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Outcome Comparison Survey (time frame: The end of the study (Week 20 to 25)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06869252, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025; AzTrials last refreshed its copy on 29 Oct 2026.