Autologous Adipose-Derived Adult Stromal Vascular Cell Transplantation for Alopecia

NCT03427905 | Unknown

• 1 other identifier: CTP-008-13-Ed-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hair Loss/Baldness; Alopecia

Outcome Measures

Primary Outcomes (1)

• Improvement of Hair loss

  Decrease in the hair loss

  6 months postoperative

Secondary Outcomes (3)

• Improvement of hair density

  6 months postoperative

• Improvement of hair diameter

  6 months postoperative

• Improvement of the pull test

  6 months postoperative

Study Arms (2)

GROUP I

ACTIVE COMPARATOR

lipoaspiration and transplantation of ADSVCs (for adipose-derived stromal vascular cells/primary fresh cells without culture) Interventions: - Procedure: Lipoaspiration; - Procedure: Transplantation

Procedure: Lipoaspiration

GROUP II

ACTIVE COMPARATOR

lipoaspiration and transplantation of ADSCs (for adipose-derived mesynchymal stem cells/after culture) Interventions: - Procedure: Lipoaspiration; - Procedure: Transplantation

Procedure: Transplantation

Interventions

Lipoaspiration PROCEDURE

Procedure: Lipoaspiration of fat and processing for the isolation of SVF Procedure: Transplantation

GROUP I

Transplantation PROCEDURE

Procedure: Lipoaspiration of fat and processing for the isolation of SVF and culture for the obtention of ADSCS Procedure: Transplantation

GROUP II

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lebanese University: lead
• Reviva Regenerative Medicine Center MEIH Hospital - REVIVA PHARMACEUTICALS (for the first group): collaborator

Study Sites (1)

Lebanese University, faculty of Sciences, section II and III

Beirut, 99, Lebanon

RECRUITING

MeSH Terms

Conditions

Alopecia

Interventions

Transplantation

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Nehman Makdissy, PhD

  Lebanese University

  PRINCIPAL INVESTIGATOR

• Rami Anderi, MD

  Lebanese University

  STUDY DIRECTOR

Central Study Contacts

Nehman A. Makdissy, PhD

CONTACT

0096171210250; almakdissy@hotmail.com

Rami Anderi, MD

CONTACT

0096895919143; cosmeclic@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: February 9, 2018
• Study Start: January 27, 2017
• Primary Completion: February 3, 2018
• Study Completion: December 30, 2018
• Last Updated: February 26, 2018

Record last verified: 2018-02

Locations

LE (1)