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Alopecia, AndrogeneticPhase 3NCT05296863

Adipose-derived Stem Cell Conditioned Media as a Novel Approach for Hair Regrowth in Male Androgenetic Alopecia

A Phase 3 study testing Non-concentrated adipose-derived stem cell conditioned media and 5% Minoxidil and Concentrated adipose-derived stem cell conditioned media and 5% Minoxidil in people with Alopecia, Androgenetic and Hair Loss/Baldness, run by Dr. dr. Lili Legiawati, SpKK(K) at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study investigated the efficacy of adipose derived stem cell conditioned media (ADSC-CM) combined with minoxidil for hair regeneration therapy in male AGA. Read more about this study

Who is it for?
Ages 25 to 58 years, men onlyHealthy volunteers can take part
Conditions the study is for
Alopecia, Androgenetic, Hair Loss/Baldness
What is being tested?
Non-concentrated adipose-derived stem cell conditioned media and 5% Minoxidil and Concentrated adipose-derived stem cell conditioned media and 5% Minoxidil
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
37 participants
Where
1 siteIndonesia
Study dates
11 Oct 2021to 3 Dec 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 58 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • males aged 25-58 years old
  • Hamilton-Norwood criteria grades II to VI
  • cessation of anti-androgens and minoxidil treatment for at least one month

Who cannot join

  • patients with hair loss other than AGA, such as alopecia areata, chemotherapy-induced alopecia, autoimmune-induced alopecia, and scalp malignancies;
  • 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.

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • Universitas Indonesia

    Jakarta Pusat, Jakarta Special Capital Region, 10430

Other trials in Indonesia

About this study

Official title: Adipose-derived Stem Cell Conditioned Media as a Novel Approach for Hair Regrowth in Male Androgenetic Alopecia: A Randomized, Double-blind Clinical Trial

This study investigated the efficacy of adipose derived stem cell conditioned media (ADSC-CM) combined with minoxidil for hair regeneration therapy in male AGA.

Read the detailed description

This study was a double-blind, randomized clinical trial (RCT). Two concentrations of ADSC-CM were utilized: concentrated and non-concentrated ADSC-CM. The scalp was divided vertically in half; one side was injected with 2 ml of ADSC-CM, while the control side received 2 ml of NaCl 0,9%. After the injection, patients applied topical 5% minoxidil twice daily. Clinical improvements were assessed using photographic evaluation and trichoscan every two weeks.

Being tested
Non-concentrated adipose-derived stem cell conditioned media and 5% Minoxidil, Concentrated adipose-derived stem cell conditioned media and 5% Minoxidil, Placebo and 5% Minoxidil
Keywords
Stem cell therapy, Adipose derived stem cell conditioned media, Hair regeneration
Medical subject headings
Alopecia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Non-concentrated adipose-derived stem cell conditioned media and 5% MinoxidilCombination product

    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% MinoxidilCombination product

    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% MinoxidilCombination product

    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.

Study groups in NCT05296863
Study groupRoleWhat they receive
Non-concentrated ADSC-CMExperimental2 ml intradermal injection of non-concentrated ADSC-CM + 1 ml of 5% topical Minoxidil daily
Receives: Combination Product: Non-concentrated adipose-derived stem cell conditioned media and 5% Minoxidil; Combination Product: Placebo and 5% Minoxidil
Concentrated ADSC-CMExperimental2 ml intradermal injection of concentrated ADSC-CM + 1 ml of 5% topical Minoxidil daily
Receives: Combination Product: Concentrated adipose-derived stem cell conditioned media and 5% Minoxidil; Combination Product: Placebo and 5% Minoxidil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hair count

    Sum of hair

    Measured: Within 6 weeks

  2. Hair density

    count/cm2

    Measured: Within 6 weeks

  3. Terminal rate

    Percentage of terminal hairs

    Measured: Within 6 weeks

  4. Vellus rate

    Percentage of terminal hairs

    Measured: Within 6 weeks

  5. Mean thickness

    In centimeters

    Measured: Within 6 weeks

  6. Total follicular units

    Unit of hair follicles

    Measured: Within 6 weeks

Secondary outcomes (1)

  1. 7-point scale

    In order to assess patient satisfaction of the research process and treatment outcome

    Measured: Within 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2022
  2. Study start11 Oct 2021
  3. Primary completion3 Dec 2021
  4. Study completion3 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05296863
Sponsor's protocol ID
KET-19UN2.F1ETIKPPM00022020
Status last verified
Mar 2022
First submitted
18 Feb 2022
Last updated
25 Mar 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Syed HA, Zito PM. Alopecia. 2024 Feb 26. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK538178/

    PubMed 30844205

  • 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.

    PubMed 28225954

  • 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.

    PubMed 34741573

  • 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.

    PubMed 34232264

  • 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.

    PubMed 24848508

  • 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.

    PubMed 30564236

  • Khandpur S, Gupta S, Gunaabalaji DR. Stem cell therapy in dermatology. Indian J Dermatol Venereol Leprol. 2021 Nov-Dec;87(6):753-767. doi: 10.25259/IJDVL_19_20.

    PubMed 34245532

  • Owczarczyk-Saczonek A, Wocior A, Placek W, Maksymowicz W, Wojtkiewicz J. The Use of Adipose-Derived Stem Cells in Selected Skin Diseases (Vitiligo, Alopecia, and Nonhealing Wounds). Stem Cells Int. 2017;2017:4740709. doi: 10.1155/2017/4740709. Epub 2017 Aug 21.

    PubMed 28904532

  • Tsuji W, Rubin JP, Marra KG. Adipose-derived stem cells: Implications in tissue regeneration. World J Stem Cells. 2014 Jul 26;6(3):312-21. doi: 10.4252/wjsc.v6.i3.312.

    PubMed 25126381

  • 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.

    PubMed 17643966

  • Fukuoka H, Suga H. Hair Regeneration Treatment Using Adipose-Derived Stem Cell Conditioned Medium: Follow-up With Trichograms. Eplasty. 2015 Mar 26;15:e10. eCollection 2015.

    PubMed 25834689

  • 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.

    PubMed 25777970

  • 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.

    PubMed 31490301

  • 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.

    PubMed 34131795

  • 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.

    PubMed 32420695

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Non-concentrated adipose-derived stem cell conditioned media and 5% Minoxidil and Concentrated adipose-derived stem cell conditioned media and 5% Minoxidil in people with Alopecia, Androgenetic and Hair Loss/Baldness, run by Dr. dr. Lili Legiawati, SpKK(K) at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hair count (time frame: Within 6 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05296863, which also lists 31 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2022.

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