Hormone DeficiencyPhase 1/2MSCSHDNCT03346967
Outcomes of Adipose Derived Mesenchymal Stem Cells on Sexual Hormone Deficiency
A Phase 1/2 study testing adipose-derived mesenchymal stem cells in people with Hormone Deficiency, run by Vinmec Research Institute of Stem Cell and Gene Technology at 1 site in Vietnam.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of adipose derived mesenchymal stem cells (AD-MSCs) therapy on sexual hormone deficiency in the middle-aged patients Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Hormone Deficiency
- What is being tested?
- adipose-derived mesenchymal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Nov 2017to 30 Mar 2020
- Phase
- Phase 1/2
- 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 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 35 years to 70 years (Male) and from 35 years to menopause age (Female)
- Male: decrease in libido, decrease in intercourse frequency, erectile dysfunction, Difficulty in concentration, testosterone level ≤ 12 nMol/dL
- Female: reduced or absent menstruation after radiation exposure or chemotherapy; Hot flushes, excessive sweating, and anxiety, together with other symptoms associated with the menopause, AMH level ≤ 2 ng/ml and/or FSH level ≥ 10 mIU/ml.
- Patients signed the informed consent form
Who cannot join
- Surgery removal of endocrine glands
- Abnormalities in the endrocrine glands
- Hormone deficiency due to diabetes and other metabolic disorders
- Active autoimmune diseases
- Current usage of immunosuppressive drugs
- Coagulation disorders
Show all 9Show fewer
- Allergy to anesthetic agents
- Severe health conditions such as cancer, failure of heart, lung, liver or kidney
- Active infections
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
Vinmec Research Institute of Stem Cell and Gene Technology
Hanoi, 10000
About this study
Official title: Evaluation of Autologous Adipose Derived Mesenchymal Stem Cells (AD-MSCs) Therapy on Sexual Hormone Deficiency in the Middle-aged Patients: an Open-label, Single-group Clinical Trial
The purpose of this study is to evaluate the safety and effectiveness of adipose derived mesenchymal stem cells (AD-MSCs) therapy on sexual hormone deficiency in the middle-aged patients
Read the detailed description
The purpose of this study is to evaluate the safety and efficiency of adipose-derived mesenchymal stem cells in 30 patients with sexual hormone deficiency at Vinmec International Hospital, Hanoi, Vietnam
- Conditions
- Hormone Deficiency
- Being tested
- adipose-derived mesenchymal stem cells
- Keywords
- AD mesenchymal stem cells;sexual hormone deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adipose-derived mesenchymal stem cellsCombination product
Collect adipose-derived mesenchymal stem cells from the patients. Adipose-derived mesenchymal stem cells will be isolated, expanded and characterized in vitro under the GMP- grade procedure
| Study group | Role | What they receive |
|---|---|---|
| Stem cell Administration for female patients | Experimental | Single Intravenous Administration of Autologous Adipose-derived Mesenchymal Stem Cells with Dosage at 1 million cells per body-weight kilogram for female patients Receives: Combination Product: adipose-derived mesenchymal stem cells |
| Stem cell Administration for male patients | Experimental | Single Intravenous Administration of Autologous Adipose-derived Mesenchymal Stem Cells with Dosage at 1 million cells per body-weight kilogram for male patients Receives: Combination Product: adipose-derived mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum levels of follicle-stimulating hormone (FSH), Anti-Mullerian Hormone (AMH) and estradiol (E2) for female and testosterone level for male
Comparison between Serum levels of follicle-stimulating hormone (FSH), Anti-Mullerian Hormone (AMH) and estradiol (E2) for female and testosterone level for male at pre and post AD-MSCs therapy
Measured: up to the 12-month period following treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start1 Nov 2017
- Primary completion28 Feb 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hormone DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- 30 patients with sexual hormone deficiency will be injected AD-MSCs
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vinmec Research Institute of Stem Cell and Gene Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liem Nguyen, PhD, Principal investigator, Vinmec Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03346967
- Sponsor's protocol ID
- VinmecRISCGT72
- Acronym
- MSCSHD
- Status last verified
- Jun 2024
- First submitted
- 14 Nov 2017
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reed-Maldonado AB, Lue TF. The Current Status of Stem-Cell Therapy in Erectile Dysfunction: A Review. World J Mens Health. 2016 Dec;34(3):155-164. doi: 10.5534/wjmh.2016.34.3.155. Epub 2016 Dec 22.
PubMed 28053944Haahr MK, Jensen CH, Toyserkani NM, Andersen DC, Damkier P, Sorensen JA, Lund L, Sheikh SP. Safety and Potential Effect of a Single Intracavernous Injection of Autologous Adipose-Derived Regenerative Cells in Patients with Erectile Dysfunction Following Radical Prostatectomy: An Open-Label Phase I Clinical Trial. EBioMedicine. 2016 Jan 19;5:204-10. doi: 10.1016/j.ebiom.2016.01.024. eCollection 2016 Mar.
PubMed 27077129Charles-de-Sa L, Gontijo-de-Amorim NF, Maeda Takiya C, Borojevic R, Benati D, Bernardi P, Sbarbati A, Rigotti G. Antiaging treatment of the facial skin by fat graft and adipose-derived stem cells. Plast Reconstr Surg. 2015 Apr;135(4):999-1009. doi: 10.1097/PRS.0000000000001123.
PubMed 25811565Nguyen Thanh L, Dam PTM, Nguyen HP, Nguyen TT, To HM, Nguyen HB, Luu NA, Hoang DM. Can Autologous Adipose-Derived Mesenchymal Stem Cell Transplantation Improve Sexual Function in People with Sexual Functional Deficiency? Stem Cell Rev Rep. 2021 Dec;17(6):2153-2163. doi: 10.1007/s12015-021-10196-w. Epub 2021 Jun 15.
PubMed 34129158
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Autologous Adipose Derived Mesenchymal Stem Cells (AD-MSCs) Therapy on Sexual Hormone Deficiency in the Middle-aged Patients: an Open-label, Single-group Clinical Trial
- ClinicalTrials.gov ID
- NCT03346967
- Acronym / sponsor ID
- MSCSHD / VinmecRISCGT72
- Conditions
- Hormone Deficiency
- Keywords
- AD mesenchymal stem cells;sexual hormone deficiency
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Vinmec Research Institute of Stem Cell and Gene TechnologyUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 20 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and effectiveness of adipose derived mesenchymal stem cells (AD-MSCs) therapy on sexual hormone deficiency in the middle-aged patients
Detailed description
The purpose of this study is to evaluate the safety and efficiency of adipose-derived mesenchymal stem cells in 30 patients with sexual hormone deficiency at Vinmec International Hospital, Hanoi, Vietnam
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 30 patients with sexual hormone deficiency will be injected AD-MSCs
| Arm | Type | Receives |
|---|---|---|
| Stem cell Administration for female patients | Experimental | Combination Product: adipose-derived mesenchymal stem cellsSingle Intravenous Administration of Autologous Adipose-derived Mesenchymal Stem Cells with Dosage at 1 million cells per body-weight kilogram for female patients |
| Stem cell Administration for male patients | Experimental | Combination Product: adipose-derived mesenchymal stem cellsSingle Intravenous Administration of Autologous Adipose-derived Mesenchymal Stem Cells with Dosage at 1 million cells per body-weight kilogram for male patients |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: 35 years to 70 years (Male) and from 35 years to menopause age (Female)
- Male: decrease in libido, decrease in intercourse frequency, erectile dysfunction, Difficulty in concentration, testosterone level ≤ 12 nMol/dL
- Female: reduced or absent menstruation after radiation exposure or chemotherapy; Hot flushes, excessive sweating, and anxiety, together with other symptoms associated with the menopause, AMH level ≤ 2 ng/ml and/or FSH level ≥ 10 mIU/ml.
- Patients signed the informed consent form
Key exclusion criteria (9 listed)
- Surgery removal of endocrine glands
- Abnormalities in the endrocrine glands
- Hormone deficiency due to diabetes and other metabolic disorders
- Active autoimmune diseases
- Current usage of immunosuppressive drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adipose-derived mesenchymal stem cellsCollect adipose-derived mesenchymal stem cells from the patients. Adipose-derived mesenchymal stem cells will be isolated, expanded and characterized in vitro under the GMP- grade procedure | Combination product | Stem cell Administration for female patients, Stem cell Administration for male patients |
Primary outcome
Serum levels of follicle-stimulating hormone (FSH), Anti-Mullerian Hormone (AMH) and estradiol (E2) for female and testosterone level for male
Time frame: up to the 12-month period following treatment
Comparison between Serum levels of follicle-stimulating hormone (FSH), Anti-Mullerian Hormone (AMH) and estradiol (E2) for female and testosterone level for male at pre and post AD-MSCs therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Results publication: PubMed 28053944Reed-Maldonado AB, Lue TF. The Current Status of Stem-Cell Therapy in Erectile Dysfunction: A Review. World J Mens Health. 2016 Dec;34(3):155-164. doi: 10.5534/wjmh.2016.34.3.155. Epub 2016 Dec 22.
- Results publication: PubMed 27077129Haahr MK, Jensen CH, Toyserkani NM, Andersen DC, Damkier P, Sorensen JA, Lund L, Sheikh SP. Safety and Potential Effect of a Single Intracavernous Injection of Autologous Adipose-Derived Regenerative Cells in Patients with Erectile Dysfunction Following Radical Prostatectomy: An Open-Label Phase I Clinical Trial. EBioMedicine. 2016 Jan 19;5:204-10. doi: 10.1016/j.ebiom.2016.01.024. eCollection 2016 Mar.
- Results publication: PubMed 25811565Charles-de-Sa L, Gontijo-de-Amorim NF, Maeda Takiya C, Borojevic R, Benati D, Bernardi P, Sbarbati A, Rigotti G. Antiaging treatment of the facial skin by fat graft and adipose-derived stem cells. Plast Reconstr Surg. 2015 Apr;135(4):999-1009. doi: 10.1097/PRS.0000000000001123.
- Derived from this study: PubMed 34129158Nguyen Thanh L, Dam PTM, Nguyen HP, Nguyen TT, To HM, Nguyen HB, Luu NA, Hoang DM. Can Autologous Adipose-Derived Mesenchymal Stem Cell Transplantation Improve Sexual Function in People with Sexual Functional Deficiency? Stem Cell Rev Rep. 2021 Dec;17(6):2153-2163. doi: 10.1007/s12015-021-10196-w. Epub 2021 Jun 15.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liem Nguyen, PhD principal investigator
Vinmec Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing adipose-derived mesenchymal stem cells in people with Hormone Deficiency, run by Vinmec Research Institute of Stem Cell and Gene Technology at 1 site in Vietnam.
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 4 inclusion and 9 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 4 Jun 2024. 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 Vietnam. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Serum levels of follicle-stimulating hormone (FSH), Anti-Mullerian Hormone (AMH) and estradiol (E2) for female and testosterone level for male (time frame: up to the 12-month period following treatment). 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 NCT03346967, which also lists 4 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 4 Jun 2024.