Alopecia Clinical Trial
— A-ADSVC-CT-AOfficial 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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | December 30, 2018 |
Est. primary completion date | February 3, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Hair loss - baldness - alopecia - Age: = 18 years - Gender: any - Willing to collaborate and to attend to the clinical follow-ups for four years - 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 Exclusion Criteria: - 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 - 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. |
Country | Name | City | State |
---|---|---|---|
Lebanon | Lebanese University, faculty of Sciences, section II and III | Beirut |
Lead Sponsor | Collaborator |
---|---|
Lebanese University | Reviva Regenerative Medicine Center MEIH Hospital - REVIVA PHARMACEUTICALS (for the first group) |
Lebanon,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improvement of Hair loss | Decrease in the hair loss | 6 months postoperative | |
Secondary | Improvement of hair density | Increase in the hair density (Trichometry) from values < 175 hair/ cm² to normal range (175 to 300 hair/ cm²) | 6 months postoperative | |
Secondary | 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) | 6 months postoperative | |
Secondary | 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) | 6 months postoperative |
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