Adipose-derived Stem Cell Conditioned Media as a Novel Approach for Hair Regrowth in Male Androgenetic Alopecia
NCT ID: NCT05296863
Last Updated: 2022-03-25
Study Results
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Basic Information
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COMPLETED
PHASE3
37 participants
INTERVENTIONAL
2021-10-11
2021-12-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Non-concentrated ADSC-CM
2 ml intradermal injection of non-concentrated ADSC-CM + 1 ml of 5% topical Minoxidil daily
Non-concentrated adipose-derived stem cell conditioned media and 5% Minoxidil
Non-concentrated ADSC-CM is given during week 0, 2, 4, and 6 on the left side of the scalp.
Minoxidil is applied twice using a spray, in the morning and at night.
Placebo and 5% Minoxidil
Intervention is given during week 0, 2, 4, and 6 on the right side of the scalp.
Minoxidil is applied twice using a spray, in the morning and at night.
Concentrated ADSC-CM
2 ml intradermal injection of concentrated ADSC-CM + 1 ml of 5% topical Minoxidil daily
Concentrated adipose-derived stem cell conditioned media and 5% Minoxidil
Intervention is given during week 0, 2, 4, and 6 on the left side of the scalp. Minoxidil is applied twice using a spray, in the morning and at night.
Placebo and 5% Minoxidil
Intervention is given during week 0, 2, 4, and 6 on the right side of the scalp.
Minoxidil is applied twice using a spray, in the morning and at night.
Interventions
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Non-concentrated adipose-derived stem cell conditioned media and 5% Minoxidil
Non-concentrated ADSC-CM is given during week 0, 2, 4, and 6 on the left side of the scalp.
Minoxidil is applied twice using a spray, in the morning and at night.
Concentrated adipose-derived stem cell conditioned media and 5% Minoxidil
Intervention is given during week 0, 2, 4, and 6 on the left side of the scalp. Minoxidil is applied twice using a spray, in the morning and at night.
Placebo and 5% Minoxidil
Intervention is given during week 0, 2, 4, and 6 on the right side of the scalp.
Minoxidil is applied twice using a spray, in the morning and at night.
Eligibility Criteria
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Inclusion Criteria
* Hamilton-Norwood criteria grades II to VI
* cessation of anti-androgens and minoxidil treatment for at least one month
Exclusion Criteria
* patients receiving 5-alpha reductase inhibitor therapy;
* patients who had received growth factor treatment (platelet-rich plasma or microneedling) for at least six months prior to the study; and
* history of hypertrophic scars or blood clotting disorders.
25 Years
58 Years
MALE
Yes
Sponsors
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Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia
OTHER_GOV
PT. Kimia Farma (Persero) Tbk
INDUSTRY
Dr. dr. Lili Legiawati, SpKK(K)
OTHER
Responsible Party
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Dr. dr. Lili Legiawati, SpKK(K)
Principal Investigator
Locations
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Universitas Indonesia
Jakarta Pusat, Jakarta Special Capital Region, Indonesia
Countries
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References
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Al Aboud AM, Syed HA, Zito PM. Alopecia. 2024 Feb 26. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK538178/
Salman KE, Altunay IK, Kucukunal NA, Cerman AA. Frequency, severity and related factors of androgenetic alopecia in dermatology outpatient clinic: hospital-based cross-sectional study in Turkey. An Bras Dermatol. 2017 Jan-Feb;92(1):35-40. doi: 10.1590/abd1806-4841.20175241.
Nestor MS, Ablon G, Gade A, Han H, Fischer DL. Treatment options for androgenetic alopecia: Efficacy, side effects, compliance, financial considerations, and ethics. J Cosmet Dermatol. 2021 Dec;20(12):3759-3781. doi: 10.1111/jocd.14537. Epub 2021 Nov 6.
Huang CH, Fu Y, Chi CC. Health-Related Quality of Life, Depression, and Self-esteem in Patients With Androgenetic Alopecia: A Systematic Review and Meta-analysis. JAMA Dermatol. 2021 Aug 1;157(8):963-970. doi: 10.1001/jamadermatol.2021.2196.
Varothai S, Bergfeld WF. Androgenetic alopecia: an evidence-based treatment update. Am J Clin Dermatol. 2014 Jul;15(3):217-30. doi: 10.1007/s40257-014-0077-5.
Ferreira JR, Teixeira GQ, Santos SG, Barbosa MA, Almeida-Porada G, Goncalves RM. Mesenchymal Stromal Cell Secretome: Influencing Therapeutic Potential by Cellular Pre-conditioning. Front Immunol. 2018 Dec 4;9:2837. doi: 10.3389/fimmu.2018.02837. eCollection 2018.
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Kim WS, Park BS, Sung JH, Yang JM, Park SB, Kwak SJ, Park JS. Wound healing effect of adipose-derived stem cells: a critical role of secretory factors on human dermal fibroblasts. J Dermatol Sci. 2007 Oct;48(1):15-24. doi: 10.1016/j.jdermsci.2007.05.018. Epub 2007 Jul 23.
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Shin H, Ryu HH, Kwon O, Park BS, Jo SJ. Clinical use of conditioned media of adipose tissue-derived stem cells in female pattern hair loss: a retrospective case series study. Int J Dermatol. 2015 Jun;54(6):730-5. doi: 10.1111/ijd.12650. Epub 2015 Mar 16.
Narita K, Fukuoka H, Sekiyama T, Suga H, Harii K. Sequential Scalp Assessment in Hair Regeneration Therapy Using an Adipose-Derived Stem Cell-Conditioned Medium. Dermatol Surg. 2020 Jun;46(6):819-825. doi: 10.1097/DSS.0000000000002128.
Lee SB, Shin HT, Byun JW, Shin J, Choi GS. Clinical efficacy of adipocyte-derived stem cells conditioned media combined with micro-injury in refractory patch of alopecia areata. Arch Dermatol Res. 2022 Aug;314(6):527-532. doi: 10.1007/s00403-021-02252-9. Epub 2021 Jun 15.
Tak YJ, Lee SY, Cho AR, Kim YS. A randomized, double-blind, vehicle-controlled clinical study of hair regeneration using adipose-derived stem cell constituent extract in androgenetic alopecia. Stem Cells Transl Med. 2020 Aug;9(8):839-849. doi: 10.1002/sctm.19-0410. Epub 2020 May 18.
Gupta AK, Quinlan EM, Venkataraman M, Bamimore MA. Microneedling for Hair Loss. J Cosmet Dermatol. 2022 Jan;21(1):108-117. doi: 10.1111/jocd.14525. Epub 2021 Oct 29.
Kumar MK, Inamadar AC, Palit A. A Randomized Controlled, Single-Observer Blinded Study to Determine the Efficacy of Topical Minoxidil plus Microneedling versus Topical Minoxidil Alone in the Treatment of Androgenetic Alopecia. J Cutan Aesthet Surg. 2018 Oct-Dec;11(4):211-216. doi: 10.4103/JCAS.JCAS_130_17.
Gajjar PC, Mehta HH, Barvaliya M, Sonagra B. Comparative Study between Mesotherapy and Topical 5% Minoxidil by Dermoscopic Evaluation for Androgenic Alopecia in Male: A Randomized Controlled Trial. Int J Trichology. 2019 Mar-Apr;11(2):58-67. doi: 10.4103/ijt.ijt_89_18.
York K, Meah N, Bhoyrul B, Sinclair R. A review of the treatment of male pattern hair loss. Expert Opin Pharmacother. 2020 Apr;21(5):603-612. doi: 10.1080/14656566.2020.1721463. Epub 2020 Feb 17.
Rossi A, Anzalone A, Fortuna MC, Caro G, Garelli V, Pranteda G, Carlesimo M. Multi-therapies in androgenetic alopecia: review and clinical experiences. Dermatol Ther. 2016 Nov;29(6):424-432. doi: 10.1111/dth.12390. Epub 2016 Jul 18.
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Banger HS, Malhotra SK, Singh S, Mahajan M. Is Early Onset Androgenic Alopecia a Marker of Metabolic Syndrome and Carotid Artery Atherosclerosis in Young Indian Male Patients? Int J Trichology. 2015 Oct-Dec;7(4):141-7. doi: 10.4103/0974-7753.171566.
Arias-Santiago S, Gutierrez-Salmeron MT, Buendia-Eisman A, Giron-Prieto MS, Naranjo-Sintes R. A comparative study of dyslipidaemia in men and woman with androgenic alopecia. Acta Derm Venereol. 2010 Sep;90(5):485-7. doi: 10.2340/00015555-0926.
Kim MW, Shin IS, Yoon HS, Cho S, Park HS. Lipid profile in patients with androgenetic alopecia: a meta-analysis. J Eur Acad Dermatol Venereol. 2017 Jun;31(6):942-951. doi: 10.1111/jdv.14000. Epub 2016 Nov 2.
Won CH, Park GH, Wu X, Tran TN, Park KY, Park BS, Kim DY, Kwon O, Kim KH. The Basic Mechanism of Hair Growth Stimulation by Adipose-derived Stem Cells and Their Secretory Factors. Curr Stem Cell Res Ther. 2017;12(7):535-543. doi: 10.2174/1574888X12666170829161058.
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Ramdasi S, Tiwari SK. Human Mesenchymal Stem Cell-Derived Conditioned Media for Hair Regeneration Applications. J Stem Cells. 2016;11(4):201-211.
Xiao S, Deng Y, Mo X, Liu Z, Wang D, Deng C, Wei Z. Promotion of Hair Growth by Conditioned Medium from Extracellular Matrix/Stromal Vascular Fraction Gel in C57BL/6 Mice. Stem Cells Int. 2020 Jun 13;2020:9054514. doi: 10.1155/2020/9054514. eCollection 2020.
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Legiawati L, Suseno LS, Sitohang IBS, Yusharyahya SN, Pawitan JA, Liem IK, Kurniawati T, Ardelia A, Paramastri K. Combination of adipose-derived stem cell conditioned media and minoxidil for hair regrowth in male androgenetic alopecia: a randomized, double-blind clinical trial. Stem Cell Res Ther. 2023 Aug 21;14(1):210. doi: 10.1186/s13287-023-03440-2.
Other Identifiers
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KET-19UN2.F1ETIKPPM00022020
Identifier Type: -
Identifier Source: org_study_id
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