Adipose Derived Stem Cells Versus Platelet Rich Plasma on Follicular Unit Extraction

checkorphan
Learn more about:
Androgenetic alopecia
Related Clinical Trial
Androgenetic Alopecia Treatment Using Varin and Cannabidiol Rich Topical Hemp Oil: A Case Series A Study to Evaluate the Efficacy and Safety of AD-208 A Phase 2a Trial of FOL-005 Topical Formulations to Investigate Hair Growth Potential and Safety in Healthy Male Volunteers Efficacy and Safety of Finlândia Hair Lotion Association on Androgenetic Alopecia Low Level Light Device as a Primary Therapy for Androgenetic Alopecia the Safety, Tolerability and PK of KX-826 in Healthy Males With Alopecia Following Topical Multiple Dose Ascending Topical Cetirizine in Androgenetic Alopecia in Females A Study Evaluating the Hair Regrowth Efficacy and Safety of ALRV5XR in Male Subjects With Hair Loss A Study Evaluating the Hair Regrowth Efficacy and Safety of ALRV5XR in Female Subjects With Hair Loss Anti-Androgen Treatment for COVID-19 A Study to Evaluate the Superiority, Efficacy and Tolerability of Combination Pantovigar With 2% Minoxidil vs 2% Minoxidil in Women With Female Pattern Hair Loss The Effect of Platelet Rich Plasma on Non-scarring Alopecia Optimizing Parameters for Long-pulsed Nd:YAG Laser for Reducing Hair Shaft Diameter HairDx Analytical Validation Study The Efficacy and Safety of Topical Valproic Acid in Preventing Hair Loss A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0002899) A Study to Evaluate and Compare Injections of Autologous Dermal Cells Into the Balding Scalp of Subjects With Hair Loss A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0002013) A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0002012) A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss Minoxidil Dose Response Study in Females Identified Through IVD Testing as Non-Responders to 5% Topical Minoxidil A Study to Evaluate and Compare Injections of Autologous Mixed Population of Dermal Cells Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0006931) A Study to Evaluate and Compare Injections of Autologous Mixed Population of Dermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0005995) A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0004669) A Study to Evaluate and Compare Injections of Autologous Mixed Population of Dermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0004542) A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0004541) To Investigate Efficacy of FOL-005 on Hair Growth on Scalp Skin Computer-Assisted Hair Implantation Using ARTAS System VS Manual Implantation Technique Hair Restoration Study To Evaluate the Pharmacokinetics and Safety of AD-208 The Utility of Platelet Rich Plasma in Hair Loss Computer-Assisted Versus Manual Hair Harvest Comparative Study Topical Bimatoprost Effect on Androgen Dependent Hair Follicles Efficacy Study of Minoxidil Lotion Versus Combined Minoxidil and Finasteride Lotion to Treat Male Pattern Hair Loss A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0004512) PAI-1 Expression in Non-scarring Hair Loss Split Wound Comparison of Trichophytic Closure Techniques for Donor Site in Hair Transplantation A Study to Evaluate the Effectiveness and Safety of 5 Percent Minoxidil Foam in the Treatment of Male Pattern Hair Loss Laser Assisted Delivery of Minoxidil in Androgenetic Alopecia Cold Plasma to Treat Hair Loss Adipose-derived SVF for Treatment of Alopecia Efficacy Study of Topical NEOSH101 to Treat Male Pattern Hair Loss Efficacy of Nutrition Supplement for Treatment of Men With Hair Loss Photosensitization Study in Androgenetic Alopecia Point-of-Care Adipose-derived Cells for Hair Growth Clinical Trial to Explore the Efficacy and Safety of DA-4001 After Topical Application Modulated Light Therapy in Participants With Pattern Hair Loss Pharmacokinetics/ Pharmacodynamics and Safety of DA-4001 in Healthy Male Subjects With Androgenic Alopecia N-Acetyl-Cysteine for Treatment of AGA in Men Clinical Trial in Females for Female Pattern Hair Loss Effects of Finasteride on Serum Prostate-Specific Antigen (0906-111) Effect of Pumpkin Seed Oil on Hair Growth in Men With Androgenetic Alopecia Evaluating the Topical Herbal Solution on the Treatment of Male Pattern Hair Loss and Comparison With Minoxidil 5% Treatment of Androgenetic Alopecia in Males and Females Microarray Analysis of Scalp Biopsies After Minoxidil Treatment Efficacy of Platelet-Rich Plasma Therapy for Androgenetic Alopecia: A Systematic Review and Meta-analysis 24 Week Clinical Trial to Evaluate Safety and Effectiveness of a Hair Growth System to Treat Male and Female Baldness A Randomized, Double-blind Clinical Trial to Evaluate the Safety and Efficacy of the X5 HairLaser for the Treatment of Androgenetic Alopecia in Males Dose-Ranging Efficacy Study of Topical NEOSH101 to Treat Male Pattern Hair Loss Minoxidil Response Testing in Males With Androgenetic Alopecia Follicular Revival in Androgenic Alopecia: Evaluating Use of Micro-needling A Novel Approach to Treating Androgenetic Alopecia in Females With Low Level Laser Therapy Study To Determine Safety & Efficacy Of Autologous Human Platelet Lysate in Androgenetic Alopecia After Hair Transplant Effectiveness and Safety of Minoxidil Foam Versus Placebo Foam for Androgenetic Alopecia Study to Assess Efficacy of Platelet-Rich Plasma in Androgenetic Alopecia The Effect of Allogeneic Human Adipose Derived Stem Cell Component Extract on Androgenic Alopecia A Study of the Safety, Tolerability, and Efficacy of Topical SM04554 Solution in Male Subjects With Androgenetic Alopecia (AGA) Evaluating the Efficacy of Microneedling in the Treatment of Androgenetic Alopecia A Phase 2 Study to Evaluate the Safety and Efficacy of CB-03-01 Solution, a Comparator Solution and Vehicle Solution in Males With Androgenetic Alopecia The Use of 5mg Finasteride Versus 200mg Spironolactone and Topical 5% Minoxidil in Treating Postmenopausal Female Androgenetic Alopecia A Study to Determine the Safety and Efficacy of Autologous Human Platelet Lysate for Treatment of Androgenetic Alopecia A Study in Male and Female Subjects With Androgenetic Alopecia Treated With ATI-50002 Topical Solution Treatment of Androgenetic Alopecia in Females, 9 Beam Treatment of Androgenetic Alopecia in Males With Theradome™ LH80 PRO Comparing Different Platelet Rich Plasma (PRP) Treatment Regimens for Management of Androgenic Alopecia Local Pharmacokinetics and Tolerability of Bimatoprost Applied to the Scalp of Male Patients With Androgenetic Alopecia Dutasteride Versus Placebo and Finasteride in Men With Androgenetic Alopecia Safety and Efficacy of Hair Stimulating Complex (HSC) on Hair Growth in Males With Androgenetic Alopecia Hair Growth Efficacy and Safety of NGF-574H in Adult With Androgenic Alopecia Plasma Rich in Growth Factors (PRGF-Endoret)in the Treatment of Androgenetic Alopecia Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia Efficacy and Safety Study to Compare Two Minoxidil Formulations on Women With Androgenetic Alopecia A Study of SM04554 Applied Topically to the Scalp of Male Subjects With Androgenetic Alopecia Analyzed by Biopsy of the Scalp Prior To and Post Dosing Treatment of Androgenetic Alopecia in Males Adipose Derived Stem Cells Versus Platelet Rich Plasma on Follicular Unit Extraction Treatment of Androgenetic Alopecia in Females, 12 Beam Nanofat Grafting for Treatment of Androgenetic Alopecia Topical Cetirizine 1% vs Minoxidil 5% Gel in Treatment of Androgenetic Alopecia Efficacy Study of a Cosmetic Lotion in the Treatment of Androgenetic Alopecia in Males and Females Treatment of Androgenic Alopecia in Males A Study Evaluating the Efficacy and Safety of SM04554 Topical Solution in Male Subjects With Androgenetic Alopecia Androgenetic Alopecia and the JAK-STAT Pathway Evaluate the Clinical Effectiveness of RegenKit Platelet-rich Plasma (PRP) in Androgenetic Alopecia Treatment Efficacy and Safety of Platelet Rich Plasma in Androgenetic Alopecia The Effect of Platelet-rich Plasma in Subjects With Androgenetic Alopecia

Brief Title

Adipose Derived Stem Cells Versus Platelet Rich Plasma on Follicular Unit Extraction

Official Title

the Effect of Adipose Derived Stem Cells Combined With Platelet Rich Plasma Versus Platelet Rich Plasma Alone on Follicular Unit Extraction Hair Transplantion in Male Androgenic Alopecia: Clinical Trial

Brief Summary

      Androgenetic alopecia is the most common type of alopecia in both men and women. About 80 %
      of Caucasian men and 40-50 % of Caucasian women are affected by androgenetic alopecia. The
      psychological impact of hair loss due to Androgenetic alopecia can be profound.

Detailed Description

      Currently, two medications are Food and Drug Administration approved in the treatment of
      Androgenetic alopecia which are minoxidil, and finasteride. Both medications must be taken
      indefinitely for benefits to persist. Hair transplantation is the only current successful
      permanent option. Nowadays, the majority of surgeons use 2 techniques, the classic strip
      technique, and the follicular unit extraction technique. Advantages of follicular unit
      extraction over the strip technique are the lesser incidence of donor zone post-procedural
      discomfort and the barely visible scarring.

      Platelet rich plasma is an autologous concentration of platelets in small volume of plasma
      and is an exciting therapeutic option for hair growth. Combining platelet rich plasma with
      follicular unit extraction surgery for the treatment of Androgenetic alopecia demonstrated
      that PRP is able to minimize the postsurgical follicle loss and potentiate the performance of
      grafted hairs.

      Adipose derived stem cells are an effective mesenchymal stem cell population with enormous
      potential in different fields of regenerative medicine.

      Adipose stem cells are needed to induce the proliferation of bulge stem cells of hair
      follicle. Furthermore, they can help in wound healing and vascular neogenesis.

      Zanzottera et al. 2014 investigated the effect of adipose derived stem cells on wound healing
      and engraftment of the transplanted hair applied during hair restoration surgery for three
      patients with androgenetic alopecia. Despite their promising results, further clinical trials
      including larger number of patients are still needed to confirm their preliminary findings.

Study Phase

Phase 4

Study Type

Interventional

Primary Outcome

hair growth

Secondary Outcome

 hair shaft diameter

Condition

Androgenetic Alopecia

Intervention

Adipose derived stem cells suspention

Study Arms / Comparison Groups

 Adipose derived stem cells suspention
Description:  suspension rich in adipose derived stem cells plus platelet rich plasma will be injected at the recipient site during follicular unit extraction for treatment of androgenetic alopecia

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Biological

Estimated Enrollment

40

Start Date

January 15, 2018

Completion Date

March 2021

Primary Completion Date

January 2021

Eligibility Criteria

        Inclusion Criteria:

          -  male patients with androgenetic alopecia between 18 years and 60 years

        Exclusion Criteria:

          1. Patients with Non-androgenetic causes of hair loss.

          2. Female patients with androgenetic alopecia.

          3. Patients who received anti-hair loss treatment within the past six months.

          4. Patients with history of bleeding disorders or on anticoagulant therapy.

          5. Patients with history of chronic liver disease, cancer or connective tissue disorders.

          6. Patients with current scalp infection.

Gender

Male

Ages

18 Years - 60 Years

Accepts Healthy Volunteers

No

Contacts

Alaa H Ghazally, MD, 01001801039, [email protected]

Location Countries

Egypt

Location Countries

Egypt

Administrative Informations

NCT ID

NCT03388840

Organization ID

ADSCPRPFUE

Responsible Party

Principal Investigator

Study Sponsor

Assiut University

Study Sponsor

Alaa H Ghazally, MD, Principal Investigator, Assiut University

Verification Date

February 2018