Alopecia Clinical Trial
Official title:
Autologous Adipose-Derived Adult Stromal Vascular Cell Transplantation for Alopecia
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.
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.
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