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Autologous Adipose-Derived Adult Stromal Vascular Cell Transplantation for Alopecia (A-ADSVC-CT-A)

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ClinicalTrials.gov Identifier: NCT03427905
Recruitment Status : Recruiting
First Posted : February 9, 2018
Last Update Posted : February 26, 2018
Sponsor:
Collaborator:
Reviva Regenerative Medicine Center MEIH Hospital - REVIVA PHARMACEUTICALS (for the first group)
Information provided by (Responsible Party):
Nehman Makdissy, Lebanese University

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 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.

Condition or disease Intervention/treatment Phase
Hair Loss/Baldness Alopecia Procedure: Lipoaspiration Procedure: Transplantation Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Autologous Adipose-Derived Adult Stromal Vascular Cell Transplantation for Alopecia
Actual Study Start Date : January 27, 2017
Actual Primary Completion Date : February 3, 2018
Estimated Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: GROUP I
lipoaspiration and transplantation of ADSVCs (for adipose-derived stromal vascular cells/primary fresh cells without culture) Interventions: - Procedure: Lipoaspiration; - Procedure: Transplantation
Procedure: Lipoaspiration
Procedure: Lipoaspiration of fat and processing for the isolation of SVF Procedure: Transplantation

Active Comparator: GROUP II
lipoaspiration and transplantation of ADSCs (for adipose-derived mesynchymal stem cells/after culture) Interventions: - Procedure: Lipoaspiration; - Procedure: Transplantation
Procedure: Transplantation
Procedure: Lipoaspiration of fat and processing for the isolation of SVF and culture for the obtention of ADSCS Procedure: Transplantation




Primary Outcome Measures :
  1. Improvement of Hair loss [ Time Frame: 6 months postoperative ]
    Decrease in the hair loss


Secondary Outcome Measures :
  1. Improvement of hair density [ Time Frame: 6 months postoperative ]
    Increase in the hair density (Trichometry) from values < 175 hair/ cm² to normal range (175 to 300 hair/ cm²)

  2. Improvement of hair diameter [ Time Frame: 6 months postoperative ]
    Increase in the hair diameter from fine hair (≤ 60 microns) to medium hair (60 to 80 microns) and thick hair (≥ 80 microns)

  3. Improvement of the pull test [ Time Frame: 6 months postoperative ]
    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)



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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03427905


Contacts
Contact: Nehman A. Makdissy, PhD 0096171210250 almakdissy@hotmail.com
Contact: Rami Anderi, MD 0096895919143 cosmeclic@hotmail.com

Locations
Lebanon
Lebanese University, faculty of Sciences, section II and III Recruiting
Beirut, Lebanon, 99
Contact: Nehman Makdissy    0096171210250    almakdissy@hotmail.com   
Sponsors and Collaborators
Lebanese University
Reviva Regenerative Medicine Center MEIH Hospital - REVIVA PHARMACEUTICALS (for the first group)
Investigators
Principal Investigator: Nehman Makdissy, PhD Lebanese University
Study Director: Rami Anderi, MD Lebanese University

Responsible Party: Nehman Makdissy, Principal Investigator, Lebanese University
ClinicalTrials.gov Identifier: NCT03427905     History of Changes
Other Study ID Numbers: CTP-008-13-Ed-001
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical