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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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  • 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.

Nehman A. Makdissy, PhD contact

0096171210250

almakdissy@hotmail.com

Rami Anderi, MD contact

0096895919143

cosmeclic@hotmail.com

Lebanon1 site, 1 recruiting
  • Lebanese University, faculty of Sciences, section II and III

    Beirut, 99

    Nehman Makdissy, 0096171210250, almakdissy@hotmail.com

    Recruiting

Other trials in Lebanon

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.

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 groups in NCT03427905
Study groupRoleWhat they receive
GROUP IActive comparatorlipoaspiration and transplantation of ADSVCs (for adipose-derived stromal vascular cells/primary fresh cells without culture) Interventions: - Procedure: Lipoaspiration; - Procedure: Transplantation
Receives: Procedure: Lipoaspiration
GROUP IIActive comparatorlipoaspiration 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.

  1. Improvement of Hair loss

    Decrease in the hair loss

    Measured: 6 months postoperative

Secondary outcomes (3)
  1. 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

  2. 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

  3. 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.

  1. First posted9 Feb 2018
  2. Study start27 Jan 2017
  3. Primary completion3 Feb 2018
  4. Study completion30 Dec 2018 (estimated)

Resources

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)
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

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.

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