Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2025-12-25 @ 3:09 AM
NCT ID:
NCT03427905
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
75 Years
Study:
NCT03427905
Study Brief:
Protocol Section:
NCT03427905