Hair Loss/BaldnessA-ADSVC-CT-ANCT03427905
Autologous Adipose-Derived Adult Stromal Vascular Cell Transplantation for Alopecia
A study testing Lipoaspiration and Transplantation in people with Hair Loss/Baldness and Alopecia, run by Lebanese University at 1 site in Lebanon.
Trial summary
Most common forms of hair loss (alopecia) are caused by aberrant hair follicle cycling and changes in hair follicle morphology. However, current treatments for alopecia do not specifically target these processes. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Hair Loss/Baldness, Alopecia
- What is being tested?
- Lipoaspiration and Transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteLebanon
- Study dates
- 27 Jan 2017to 30 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hair loss
- baldness
- alopecia
- Age: ≥ 18 years
- Gender: any
- Willing to collaborate and to attend to the clinical follow-ups for four years
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- Patients willing to sign informed consent
- Able and willing to comply with all study requirements
- Patients with no hereditary diseases of the hair, with no burns
- Medically suitable to undergo cell's graft surgery with local anesthesia
- Normal serum chemistry and hematology screening tests
- Negative human immunodeficiency virus (HIV), hepatitis B (HBV), hepatitis C (HCV) serology
- No history of malignancy
- Complete history \& physical examination
- Negative chest roentgenogram (CXR)
- Negative urinalysis (U/A)
- Normal thyroid exam
Who cannot join
- Patients not willing to sign informed consent
- Defects in hair scalp with a potential to affect the graft outcome
- Severe hair loss and baldness
- Infection
- Known allergy
- Known coagulation abnormalities
Show all 15Show fewer
- Any medical condition likely interferes to cause serious adverse events during the study
- History of malignancy
- History of cognitive impairments or dementia which may impact the patient's ability to participate in the informed consent process and to appropriately complete evaluations
- Any immunodeficiency
- Any current immunosuppressive therapy other than intermittent or low dose corticosteroids
- Renal insufficiency, as defined by creatine level >1.3 mg/dL.
- Serologic evidence of infection with Hepatitis B, Hepatitis C, or HIV
- If female, pregnancy or lactation.
- Any other medical condition, which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromises patient safety or interferes with the interpretation of the study results.
Trial locations and contacts
1 site in 1 country.
Lebanon1 site, 1 recruiting
- Recruiting
Lebanese University, faculty of Sciences, section II and III
Beirut, 99
Nehman Makdissy, 0096171210250, almakdissy@hotmail.com
About this study
Most common forms of hair loss (alopecia) are caused by aberrant hair follicle cycling and changes in hair follicle morphology. However, current treatments for alopecia do not specifically target these processes. Adipose-derived stromal vascular cells (ADSVCs) that can be harvested from fat cells are one of the latest breakthroughs in the aesthetic field. The potential use of stem cell-based therapies for the repair and regeneration of various tissues and organs offers a paradigm shift that may provide alternative therapeutic solutions. This study aimed at the presentation of clinical cases to suggest a therapeutic plan comprised of acquisition of small volume of fat, followed by injection of ADSVCs in the scalp. 20 patients will be recruited for this study (considering the second group). Hair regeneration will be assessed by the pull test, hair quality, and hair density. All patients must show increased significant improvement of the hair quality and density. The obtained results must prove the efficacy and the safety of the treatment and satisfaction of the patient that will confirm the quality of the results.
Read the detailed description
Hair loss is one of the most common complaints among all patients consulting a dermatologist and is usually associated with severe psychological disturbances, distress, and symptoms of depression. Most common forms of hair loss (alopecia) are caused by aberrant hair follicle cycling and changes in hair follicle morphology. Cells with stem cell properties have recently been described in many integument appendages including feathers and teeth, but the hair follicle stands out as one of the best model systems for studying adult stem cells. Hair follicles are accessible, well defined in terms of their developmental biology, and their stem cell populations are located in discrete compartments or niches.
There are three phases of hair growth, which every hair follicle undergoes. The first phase is when follicles undergo extremely rapid epithelial cell division and execute exquisitely timed differentiation programs when in the growing (Anagen) phase. The second phase is when follicles growth stops during a certain period, the (Catagen) phase. The third phase is when most follicles regress into structures that resemble immature developing follicles, after which they go into a period of mitotic quiescence, the (Telogen) phase. Stem cells are at the core of all hair dynamic events that includes a new burst of activity and further morphogenetic remodeling as the follicle grows again at the start of a new Anagen phase.
The term "Stem Cell" is given to a cell which has the ability to self-renew as well as to differentiate into defined cellular subtypes. Multipotent stem cells are present in different adult tissues such as bone marrow, dental pulp, adipose tissue, etc. and within the adipose tissue the adipose-derived stromal vascular cells (ADSVCs), which are one of the most promising stem cell population identified since the human adipose tissue is easily obtained in large quantities with little patient discomfort and secretory factors from ADSVCs have been considered as a promising therapy for skin aging. Therefore, the use of autologous ADSVCs can be promising for hair loss. Since the stromal vascular fraction (SVF) is saturated with stem cells among other cells derived from adipose tissue, cells can be called ADSVFC if they are used freshly, or ADSC/ADASC or others terms in cases of primary cells placed in culture having then the adherent feature, resulting in a set of mesenchymal stem cells (MSCs). In fact, contrary to cultured ADSCs, freshly isolated ADSVCs were shown to be highly positive for CD34, and positive for CD117 and HLA-DR. MSCs derived from adipose tissue when obtained by culture are mostly negative for CD34, and HLA-DR. This indicates clearly that primary cells are significantly more promising in cases of need to maintain a certain level of CD34 in the graft.
In the present study, the investigators aimed to use autologous ADSVCs graft for the treatment of alopecia and to assess the safety and effectiveness of the transplantation. This ADSVCs group will be compared to a group of cultured ADSCs. In fact, the study is divided into 2 groups: ADCVCs and ADSCs, where the first group had been started in 2013 and since 2016, the investigators aimed to add a comparative group by using the cultured ADSCs instead of the primary non-cultured ADSVCs. (Note: the investigators started using grafts of PRP (Platelets Rich Plasma) in 2013 before using isolated adipose-derived cells, where no significant improvement in the hair quality was observed. Then, the investigators aimed to use adipose-derived cells firstly without culture and secondly subjected to culture. The first group was done in collaboration with Reviva Regenerative Medicine Center at the Middle East Institute of Health University Hospital at Bsalim Lebanon. The second group will be realized with a collaborator to be defined by the Lebanese University after approval of the administration and corresponding committee.
The process flow is defined as following: (1) the file study: which start by receiving the file of the patient, the file will be forwarded to appointed physician coordinator for review and submission of medical report (Here Dr. Rami Anderi), then the medical report will be evaluated by the cell therapy committee and the patient will be asked for clinical examination, and after consultation a reply to the patient with medical decision will follow with an approval or not be recruited and if yes, a brief report about the procedure will be submitted and explained in details to the patient, a consent form must be signed if the patient agrees to be included in the study, (2) the patient admission: which may start by completion of the procedure forms and doing the pre-op evaluation (initial work up defined as a clinical and biological assessment upon C.A.S), followed by lipoaspiration of the subcutaneous adipose tissue to be performed by the plastic surgeon, then sample processing for isolation and characterization of the stromal vascular fraction enriched with ADSVCs (the quality control assessment will be realized before and after all the steps of the procedure starting from the SVF collection to transplantation; (3) the delivery (transplantation). The patient will be put on antibiotic/anti-inflammatory for a defined period and followed by the team at 1 week, 3 months, and 6 months.
- Conditions
- Hair Loss/Baldness, Alopecia
- Being tested
- Lipoaspiration, Transplantation
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LipoaspirationProcedure or surgery
Procedure: Lipoaspiration of fat and processing for the isolation of SVF Procedure: Transplantation
TransplantationProcedure or surgery
Procedure: Lipoaspiration of fat and processing for the isolation of SVF and culture for the obtention of ADSCS Procedure: Transplantation
| Study group | Role | What they receive |
|---|---|---|
| GROUP I | Active comparator | lipoaspiration and transplantation of ADSVCs (for adipose-derived stromal vascular cells/primary fresh cells without culture) Interventions: - Procedure: Lipoaspiration; - Procedure: Transplantation Receives: Procedure: Lipoaspiration |
| GROUP II | Active comparator | lipoaspiration and transplantation of ADSCs (for adipose-derived mesynchymal stem cells/after culture) Interventions: - Procedure: Lipoaspiration; - Procedure: Transplantation Receives: Procedure: Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of Hair loss
Decrease in the hair loss
Measured: 6 months postoperative
Secondary outcomes (3)
Improvement of hair density
Increase in the hair density (Trichometry) from values < 175 hair/ cm² to normal range (175 to 300 hair/ cm²)
Measured: 6 months postoperative
Improvement of hair diameter
Increase in the hair diameter from fine hair (≤ 60 microns) to medium hair (60 to 80 microns) and thick hair (≥ 80 microns)
Measured: 6 months postoperative
Improvement of the pull test
Decrease in the pull test measures (from 3-8 to 0-1; the number of extracted pulled hairs must be between 0 and 1 in normal patients)
Measured: 6 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start27 Jan 2017
- Primary completion3 Feb 2018
- Study completion30 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lebanese University
- Sponsor type
- University, hospital or other
- Collaborators
- Reviva Regenerative Medicine Center MEIH Hospital - REVIVA PHARMACEUTICALS (for the first group)
- Responsible party
- Principal investigator, Nehman Makdissy, Lebanese University
- Investigators
- Nehman Makdissy, PhD, Principal investigator, Lebanese UniversityRami Anderi, MD, Study director, Lebanese University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03427905
- Sponsor's protocol ID
- CTP-008-13-Ed-001
- Acronym
- A-ADSVC-CT-A
- Status last verified
- Feb 2018
- First submitted
- 30 Jan 2018
- Last updated
- 26 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Adipose-Derived Adult Stromal Vascular Cell Transplantation for Alopecia
- ClinicalTrials.gov ID
- NCT03427905
- Acronym / sponsor ID
- A-ADSVC-CT-A / CTP-008-13-Ed-001
- Conditions
- Hair Loss/Baldness, Alopecia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Lebanese UniversityUniversity, hospital or other
- Collaborators
- Reviva Regenerative Medicine Center MEIH Hospital - REVIVA PHARMACEUTICALS (for the first group)
- Study start
- 27 Jan 2017 (actual)
- Primary completion
- 3 Feb 2018 (actual)
- Study completion
- 30 Dec 2018 (estimated)
- First posted
- 9 Feb 2018 (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.
Most common forms of hair loss (alopecia) are caused by aberrant hair follicle cycling and changes in hair follicle morphology. However, current treatments for alopecia do not specifically target these processes. Adipose-derived stromal vascular cells (ADSVCs) that can be harvested from fat cells are one of the latest breakthroughs in the aesthetic field. The potential use of stem cell-based therapies for the repair and regeneration of various tissues and organs offers a paradigm shift that may provide alternative therapeutic solutions. This study aimed at the presentation of clinical cases to suggest a therapeutic plan comprised of acquisition of small volume of fat, followed by injection of ADSVCs in the scalp. 20 patients will be recruited for this study (considering the second group). Hair regeneration will be assessed by the pull test, hair quality, and hair density. All patients must show increased significant improvement of the hair quality and density. The obtained results must prove the efficacy and the safety of the treatment and satisfaction of the patient that will confirm the quality of the results.
Detailed description
Hair loss is one of the most common complaints among all patients consulting a dermatologist and is usually associated with severe psychological disturbances, distress, and symptoms of depression. Most common forms of hair loss (alopecia) are caused by aberrant hair follicle cycling and changes in hair follicle morphology. Cells with stem cell properties have recently been described in many integument appendages including feathers and teeth, but the hair follicle stands out as one of the best model systems for studying adult stem cells. Hair follicles are accessible, well defined in terms of their developmental biology, and their stem cell populations are located in discrete compartments or niches.
There are three phases of hair growth, which every hair follicle undergoes. The first phase is when follicles undergo extremely rapid epithelial cell division and execute exquisitely timed differentiation programs when in the growing (Anagen) phase. The second phase is when follicles growth stops during a certain period, the (Catagen) phase. The third phase is when most follicles regress into structures that resemble immature developing follicles, after which they go into a period of mitotic quiescence, the (Telogen) phase. Stem cells are at the core of all hair dynamic events that includes a new burst of activity and further morphogenetic remodeling as the follicle grows again at the start of a new Anagen phase.
The term "Stem Cell" is given to a cell which has the ability to self-renew as well as to differentiate into defined cellular subtypes. Multipotent stem cells are present in different adult tissues such as bone marrow, dental pulp, adipose tissue, etc. and within the adipose tissue the adipose-derived stromal vascular cells (ADSVCs), which are one of the most promising stem cell population identified since the human adipose tissue is easily obtained in large quantities with little patient discomfort and secretory factors from ADSVCs have been considered as a promising therapy for skin aging. Therefore, the use of autologous ADSVCs can be promising for hair loss. Since the stromal vascular fraction (SVF) is saturated with stem cells among other cells derived from adipose tissue, cells can be called ADSVFC if they are used freshly, or ADSC/ADASC or others terms in cases of primary cells placed in culture having then the adherent feature, resulting in a set of mesenchymal stem cells (MSCs). In fact, contrary to cultured ADSCs, freshly isolated ADSVCs were shown to be highly positive for CD34, and positive for CD117 and HLA-DR. MSCs derived from adipose tissue when obtained by culture are mostly negative for CD34, and HLA-DR. This indicates clearly that primary cells are significantly more promising in cases of need to maintain a certain level of CD34 in the graft.
In the present study, the investigators aimed to use autologous ADSVCs graft for the treatment of alopecia and to assess the safety and effectiveness of the transplantation. This ADSVCs group will be compared to a group of cultured ADSCs. In fact, the study is divided into 2 groups: ADCVCs and ADSCs, where the first group had been started in 2013 and since 2016, the investigators aimed to add a comparative group by using the cultured ADSCs instead of the primary non-cultured ADSVCs. (Note: the investigators started using grafts of PRP (Platelets Rich Plasma) in 2013 before using isolated adipose-derived cells, where no significant improvement in the hair quality was observed. Then, the investigators aimed to use adipose-derived cells firstly without culture and secondly subjected to culture. The first group was done in collaboration with Reviva Regenerative Medicine Center at the Middle East Institute of Health University Hospital at Bsalim Lebanon. The second group will be realized with a collaborator to be defined by the Lebanese University after approval of the administration and corresponding committee.
The process flow is defined as following: (1) the file study: which start by receiving the file of the patient, the file will be forwarded to appointed physician coordinator for review and submission of medical report (Here Dr. Rami Anderi), then the medical report will be evaluated by the cell therapy committee and the patient will be asked for clinical examination, and after consultation a reply to the patient with medical decision will follow with an approval or not be recruited and if yes, a brief report about the procedure will be submitted and explained in details to the patient, a consent form must be signed if the patient agrees to be included in the study, (2) the patient admission: which may start by completion of the procedure forms and doing the pre-op evaluation (initial work up defined as a clinical and biological assessment upon C.A.S), followed by lipoaspiration of the subcutaneous adipose tissue to be performed by the plastic surgeon, then sample processing for isolation and characterization of the stromal vascular fraction enriched with ADSVCs (the quality control assessment will be realized before and after all the steps of the procedure starting from the SVF collection to transplantation; (3) the delivery (transplantation). The patient will be put on antibiotic/anti-inflammatory for a defined period and followed by the team at 1 week, 3 months, and 6 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP I | Active comparator | Procedure: Lipoaspirationlipoaspiration and transplantation of ADSVCs (for adipose-derived stromal vascular cells/primary fresh cells without culture) Interventions: - Procedure: Lipoaspiration; - Procedure: Transplantation |
| GROUP II | Active comparator | Procedure: Transplantationlipoaspiration and transplantation of ADSCs (for adipose-derived mesynchymal stem cells/after culture) Interventions: - Procedure: Lipoaspiration; - Procedure: Transplantation |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Hair loss
- baldness
- alopecia
- Age: ≥ 18 years
- Gender: any
Key exclusion criteria (15 listed)
- Patients not willing to sign informed consent
- Defects in hair scalp with a potential to affect the graft outcome
- Severe hair loss and baldness
- Infection
- Known allergy
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 |
|---|---|---|
| LipoaspirationProcedure: Lipoaspiration of fat and processing for the isolation of SVF Procedure: Transplantation | Procedure or surgery | GROUP I |
| TransplantationProcedure: Lipoaspiration of fat and processing for the isolation of SVF and culture for the obtention of ADSCS Procedure: Transplantation | Procedure or surgery | GROUP II |
Primary outcome
Improvement of Hair loss
Time frame: 6 months postoperative
Decrease in the hair loss
3 secondary outcomes
Improvement of hair density
Time frame: 6 months postoperative
Improvement of hair diameter
Time frame: 6 months postoperative
Improvement of the pull test
Time frame: 6 months postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Hair Loss/Baldness
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Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of N1087 in Participants With Female Pattern Hair Loss (MINORA-WOMEN)
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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. This study is not recruiting at the moment.
Nehman Makdissy, PhD principal investigator
Lebanese University
Rami Anderi, MD study director
Lebanese University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lipoaspiration and Transplantation in people with Hair Loss/Baldness and Alopecia, run by Lebanese University at 1 site in Lebanon.
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 17 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 26 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nehman A. Makdissy, PhD (0096171210250, almakdissy@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of Hair loss (time frame: 6 months postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Feb 2018.