Status:
UNKNOWN
Autologous Adipose-Derived Adult Stromal Vascular Cell Transplantation for Alopecia
Lead Sponsor:
Lebanese University
Collaborating Sponsors:
Reviva Regenerative Medicine Center MEIH Hospital - REVIVA PHARMACEUTICALS (for the first group)
Conditions:
Hair Loss/Baldness
Alopecia
Eligibility:
All Genders
21-75 years
Phase:
NA
Brief 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 thes...
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. Mos...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03427905
Start Date
January 27 2017
End Date
December 30 2018
Last Update
February 26 2018
Active Locations (1)
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1
Lebanese University, faculty of Sciences, section II and III
Beirut, Lebanon, 99