UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045897 |
|---|---|
| Receipt number | R000052378 |
| Scientific Title | Clinical study on the efficacy and safety of autologous micrograft (Rigenera) and dental pulp-derived stem cell conditioned medium (SHED-CM) on hair loss |
| Date of disclosure of the study information | 2021/10/28 |
| Last modified on | 2023/05/10 14:07:26 |
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Basic information
Public title
Clinical study on the efficacy and safety of autologous micrograft (Rigenera) and dental pulp-derived stem cell conditioned medium (SHED-CM) on hair loss
Acronym
Clinical study of autologous micrograft and SHED-CM
Scientific Title
Clinical study on the efficacy and safety of autologous micrograft (Rigenera) and dental pulp-derived stem cell conditioned medium (SHED-CM) on hair loss
Scientific Title:Acronym
Clinical study of autologous micrograft and SHED-CM
Region
| Japan |
Condition
Condition
Alopecia
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of autologous micrograft and dental pulp-derived stem cell conditioned medium on hair loss
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Phototrichogram of injection site, vital signs, and adverse events until 6 month after starting treatment
Key secondary outcomes
Hair density, hair diameters, and vellus hair percentage before and after 6 months of treatment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
SHED-CM injection(once a month for three months)
Interventions/Control_2
After SHED-CM injection (once a month for three months), one dose of Rigenera, followed by another SHED-CM injection (once a month for three months)
Interventions/Control_3
After one dose of Rigenera, SHED-CM injection (once a month for three months)
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Blood test criteria
RBC: at least 3000,000/microL
Hemoglobin: at least10.0 g/dL
Hematocrit: at least 30.0%
WBC: between 3,000-12,000/microL
Platelets: at least 100,000/microL
2) no scalp inflammation
3) no systemic symptoms such as fever, lethargy, etc.
4) negative for HIV and syphilis serological tests within 12 weeks from the time of criteria assessment
5) no duplication with other clinical trial while participating in this study
6) ability to comprehend and give written consent to this clinical study
Key exclusion criteria
1) those who were diagnosed as having alopecia areata subtype
2) those with nickel allergy (in case of RIGENERA treatment)
3) those with connective tissue disease or systemic diseases such as chronic thyroiditis which are associated with alopecia
4) those with hair loss due to infection or malignant tumor
5) those with immunosuppressive treatment
6) those with diagnosis of malignant tumor (including pre-cancerous lesions), except for those who have no signs of recurrence for 5 years after being diagnosed as complete remission following the standard cancer treatment
7) those with skin diseases that could affect the scalp such as seborrheic dermatitis, scalp psoriasis, atopic dermatitis, etc.) and keloids
8) those with autoimmune diseases, hematological diseases, platelet dysfunction
9) those with heart failure, renal stone, severe renal failure, liver dysfunction, hypothyroidism
10) those with fever associated with acute infection
11) those suspicious of having immunodeficiency or opportunistic infection
12) those taking anticoagulant therapy
13) those who cannot commute to the study site
14) those who are diagnosed as being difficult to undergo treatment due to the presence of mental illness or mental symptoms
15) those who are not appropriate to participate in the study according to the doctor's decision
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | Kamishima |
Organization
Tokyo Midtown Skin/Aesthetic Clinic Noage
Division name
Department of Dermatology
Zip code
107-6206
Address
Midtown Tower 6F, 9-7-1 Akasaka, Minato-ku, Tokyo, 107-6206, Japan
TEL
03-5793-8712
t-kamishima@tokyomidtown-mc.jp
Public contact
Name of contact person
| 1st name | Kyoko |
| Middle name | |
| Last name | Uemura |
Organization
Advanced Medical Care Inc.
Division name
Aging Care Division
Zip code
107-6206
Address
Engyo Building 7F, 7-15-14 Roppongi, Minato-ku, Tokyo, 106-0032, Japan
TEL
03-5413-0371
Homepage URL
k-uemura@amcare.co.jp
Sponsor or person
Institute
Tokyo Midtown Center for Advanced Medical Science and Technology
Institute
Department
Personal name
Funding Source
Organization
Tokyo Midtown Center for Advanced Medical Science and Technology
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Midtown Medical Center Ethical Review Board
Address
Midtown Tower 6F, 9-7-1 Akasaka, Minato-ku, Tokyo, 107-6206, JAPAN
Tel
03-3231-2062
y-nishimoto@amare.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | Month | 28 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/10.1111/jocd.15799
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1111/jocd.15799
Number of participants that the trial has enrolled
33
Results
SHED-CM was effective for 75% of subjects regardless of disease severity, concomitant DHT-inhibitor use, and age. We also found that clinical hair status evaluated by absolute values of three quantitative trichoscopic factors (maximum hair diameter, vellus hair rate, and multi-hair follicular unit rate) showed a good correlation with H-N C stages, and what is more, a scoring system of these three factors can be a possible predictor of SHED-CM efficacy.
Results date posted
| 2023 | Year | 05 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We first screened 88 healthy male AGA patients with vertex shedding who visited the dermatology department of Tokyo Midtown Skin and Aesthetic Clinic from March 2021 to December 2022. All subjects had a physical examination and blood test to exclude severe systemic diseases, or hair loss diseases other than AGA. Those receiving DHT-inhibitors (oral finasteride or dutasteride) for less than 6 months or other AGA treatment were excluded. Among them, 33 subjects aged 27 to 69 were enrolled.
Participant flow
Manual microinjections of SHED-CM in affected areas were administered in deep dermis with 34G quadruple-tip needles,injecting 0.1 mL into each injection site, 1 cm apart. A total volume of 4.5 mL was injected each session.Before the treatment and at the 3rd, 6th, and 9th month (T3, T6, T9 month) after the initial treatment, global and close contact trichoscopic photographs were taken to evaluate hair status. All subjects were classified by H-N C at baseline (T0) and subsequent improvements were noted. Trichoscopic images were taken with a dermocamera around the hair whorls. the benchmark of the measurement area was set within a 5 x 5 mm whorl centering grid measuring hair shaft diameters (HD), hair count of each follicular unit, total number of follicular unit (TFU).
Adverse events
Mild adverse events, such as small hemorrhages and needle pain at the injection sites, were observed in all subjects on treatment day. Neither existed at the next day of treatment.
Outcome measures
1) Correlation between H-N C and trichoscopical factors
2) Scoring system of three quantitative trichoscopic factors (3QTF)
3) Efficacy of SHED-CM treatment evaluated by H-N C and 3QTF
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2021 | Year | 02 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 10 | Month | 28 | Day |
Last modified on
| 2023 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052378
