Female Sexual DysfunctionPhase 1/2IEAAMSC-W40-50NCT06726538
Investigating the Efficacy of Autologous, Adipose-derived Mesenchymal Stem Cell Therapy for the Treatment of Sexual Function Impairment in Women Aged 40-50
A Phase 1/2 study testing Intravenous administration of Autologous, adipose-derived mesenchymal stem cells in people with Female Sexual Dysfunction, run by Vinmec Research Institute of Stem Cell and Gene Technology at 2 sites in Vietnam.
Trial summary
Female Sexual Dysfunction (FSD) represents a critical public health challenge, significantly impacting women's physical, psychological, and social well-being. Despite its prevalence, cultural barriers in Vietnam and other Asian countries often limit awareness and research on FSD. Read more about this study
- Who is it for?
- Ages 40 to 50 years, women only
- Conditions the study is for
- Female Sexual Dysfunction
- What is being tested?
- Intravenous administration of Autologous, 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
- 50 participants
- Where
- 2 sitesVietnam
- Study dates
- 1 Oct 2023to 1 Jan 2026
- 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 40 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women between 40 - 50 years of age and have not gone through menopause
- The last menstrual period before participating in the study at least 2 months or more
- FSH before the menopause (tested on 2nd - 7th day of the menstrual cycle): FSH ≤ 29.8 mIU/mL
- FSFI < 26.55 ± signs of decline in sexual or reproductive functions such as symptoms of premenopausal such as hot flashes, excessive sweating, headaches
- Normal liver function
- Normal kidney function
- Normal cardiovascular function
Who cannot join
- Previous surgery to remove gonads
- Diagnosed with cancer
- Had an organ transplant
- Has congenital malformations related to the gonads
- Diagnosed with chronic diseases such as diabetes, hypopituitarism, adrenal insufficiency, and blood pressure unresponsive to treatment
- Diagnosis of active autoimmune diseases
Trial locations and contacts
2 sites in 1 country.
Vietnam2 sites
Vinmec Research Institute of Stem Cell and Gene Technology
Hanoi, 100000
Vinmec Times City International Hospital
Hanoi, 100000
About this study
Official title: Investigating the Efficacy of Autologous, Adipose-derived Mesenchymal Stem Cell Therapy in Women Aged 40-50
Female Sexual Dysfunction (FSD) represents a critical public health challenge, significantly impacting women's physical, psychological, and social well-being. Despite its prevalence, cultural barriers in Vietnam and other Asian countries often limit awareness and research on FSD. Existing treatments, such as hormone therapy, carry risks like cardiovascular complications and cancer, emphasizing the need for innovative interventions. This study investigates FSD-related factors and evaluates the efficacy of autologous adipose-derived mesenchymal stem cell (MSC) therapy as a novel approach.
In this phase 2 clinical trial, MSCs are intravenously administered at a dose of 10^6 cells/kg. These autologous cells, which are non-immunogenic, survive for approximately 8 weeks and release growth factors and cytokines to enhance vascular supply, reduce harmful inflammation, and counteract cellular aging. The study enrolls 50 female participants randomized into two groups: Group A receives MSC infusions at months 0 and 3, while Group B acts as a control for 6 months.
Outcomes are assessed through clinical evaluations, blood tests for hormonal levels, molecular analyses, and internationally validated quality-of-life and sexual function scales. Evaluations are conducted at baseline, 3, and 6 months post-infusion. This research seeks to provide robust evidence for the safety and efficacy of MSC therapy, offering a promising alternative to conventional treatments while addressing a critical gap in women's health.
Read the detailed description
Female Sexual Dysfunction (FSD) is a significant public health concern. FSD can lead to various health issues and increase the risk of developing other conditions such as osteoporosis, cardiovascular diseases, and cancer. Although hormone therapy is commonly used to treat FSD, its long-term use may have adverse effects on cardiovascular health and raise the risk of cancer. Therefore, exploring new, safe, and effective treatment methods is essential. In 2015, the FDA approved the use of flibanserin (Addyi® Sprout Pharmaceuticals, USA) for premenopausal women with reduced sexual desire. However, this therapy remains controversial due to its potential side effects and limited efficacy. Current treatments for Female Sexual Dysfunction (FSD) mainly involve hormone replacement therapy, gonadotropin therapy, dietary supplements, or lifestyle modifications. While hormone therapy is commonly used to address hormonal decline in women, long-term use may lead to cardiovascular issues or cancer. Therefore, exploring psychological therapies and researching new potential treatments to meet patients' needs is essential.
Recent studies suggest that mesenchymal stem cells (MSCs) offer a safe approach to restoring hormone deficiencies. Clinical trials have investigated the use of MSC transplants to treat conditions like premature ovarian failure and ovarian cancer. Numerous trials have employed MSCs derived from bone marrow, umbilical cords, adipose tissue, or menstrual blood to address ovarian and uterine dysfunctions. Edessy et al. reported using autologous stem cells to treat 10 participants with premature ovarian failure. Following transplantation, two participants resumed menstruation within three months, one of whom became pregnant after 11 months and delivered a healthy full-term baby. Hormonal tests in the pregnant case revealed restored levels of FSH, LH, E2, and AMH to normal ranges. Although these studies are limited by small sample sizes and the lack of control groups, they highlight the potential of MSC transplantation as a treatment for FSD.
A study by Mashayekhi et al. demonstrated the safety of autologous adipose-derived mesenchymal stem cell (MSC) therapy for premature ovarian failure, with no adverse effects reported among nine participants receiving different cell doses. Menstruation resumed in two participants in both the high-dose (15x10^6 cells/kg) and lower-dose (5x10^6 and 10x10^6 cells/kg) groups, while serum FSH levels improved in four participants. Despite small sample size and lack of a control group, the study supports the safety of MSC infusion into the ovaries. Another ongoing trial (NCT01853501) aims to further investigate MSC therapy for ovarian failure, though results are pending. In Vietnam, the Vinmec Institute of Stem Cell and Gene Technology conducted a study on Female Sexual Dysfunction (FSD), using intravenous MSC infusions for 16 women. The trial reported no adverse effects, with participants reporting improved satisfaction with sexual health, though hormone levels (AMH, FSH, and E2) showed no significant changes.
This study aims to address the need for a novel and more effective approach to treating hormonal decline in women, not only improving sexual function but also enhancing their quality of life. Based on this rationale, we have decided to conduct the study titled "Investigating the efficacy of autologous, adipose-derived mesenchymal stem cell therapy for the treatment of sexual function impairment in women aged 40-50," with the following objective: Evaluate the improvement in sexual function among women aged 40-50 years who received autologous adipose-derived mesenchymal stem cell (MSC) therapy.
- Conditions
- Female Sexual Dysfunction
- Being tested
- Intravenous administration of Autologous, adipose-derived mesenchymal stem cells
- Keywords
- female sexual dysfunction, sexual function impairment, adipose-derived mesenchymal stem cell therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous administration of Autologous, adipose-derived mesenchymal stem cellsBiological
Patients in group A will receive two infusions of autologous, adipose-derived mesenchymal stem cells at day 0 and day 90 ± 14 at a dose of 10^6 cells/kg.
Autologous, adipose-derived mesenchymal stem cells used in this study were harvested from autologous fat tissue through an enzyme method and expanded using our in-house optimized serum-free and xeno-free culture under a physiological oxygen concentration of 5%. For clinical use, cells at passage 3 will be harvested in 100 mL Ringer's lactate. Therapeutic ASC products must pass the following releasing criteria: (1) negative for bacteria, fungi and mycoplasma; (2) more than 90% viability; (3) expression of more than 95% positivity for CD105, CD73, and CD90 and less than 2% positivity for CD45, CD34, CD11b, CD19, and HLA-DR; and (4) endotoxin <5 EU/kg. The patient will be infused with 1x106 cells/kg body weight within 60 minutes via the intravenous route.
| Study group | Role | What they receive |
|---|---|---|
| MSC infusion group (Group A) | Experimental | This clinical trial involves intravenous administration of MSCs at a dose of 10^6 cells/kg, offering a non-rejection approach due to the autologous nature of the cells. These cells, surviving approximately 8 weeks in the body, secrete growth factors and cytokines to nourish cells, enhance vascular supply, and mitigate harmful inflammation, thereby countering cellular aging. Fifty female participants will be randomly assigned to two groups. Group A will receive mesenchymal stem cell (MSC) infusions twice: once at baseline and a second time three months later. Receives: Biological: Intravenous administration of Autologous, adipose-derived mesenchymal stem cells |
| Control group (Group B) | No intervention | 25 participants in Group B will act as controls for 6 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety of autologous, adipose-derived mesenchymal stem cell therapy based on The number of adverse events (AEs) and serious adverse events (SAEs)
Adverse Events (AEs): refer to any unfavorable or unintended signs, symptoms, or diseases that occur in a participant during a study or treatment, regardless of whether they are causally related to the intervention.
Serious Adverse Events (SAEs): Events are a subset of adverse events that meet specific criteria (e.g., hospitalization, life-threatening situations) indicating a higher level of severity.
Measured: at baseline, 3, and 6 months post-infusion
Changes in sexual functions of participants based on the Female Sexual Function Index
based on the Self-Assessment Questionnaires: the Vietnamese versions of Female Sexual Function Index (FSFI). The Female Sexual Function Index (FSFI) is a 19-item questionnaire scored on a 5-point Likert scale, designed to assess six key domains of female sexual function: desire, arousal, lubrication, orgasm, satisfaction, and pain. Total scores range from 2 to 36, with higher scores indicating better sexual function, while scores below 26.55 suggest a risk of dysfunction.
Measured: at baseline, 3, and 6 months post-infusion
Changes in sexual functions of participants based on the AMS Diagnosing Menopause
The Self-Assessment Questionnaires: the AMS Diagnosing Menopause (AMS): the severity of problem is scored as follows score: None =0; Mild =1; Moderate =2; Severe =3. The symptoms are grouped into 4 categories, vasomotor, psychological, locomotor and urogenital. A score of 15 or over usually indicates lower sexual function
Measured: at baseline, 3, and 6 months post-infusion
Changes in sexual functions of participants based on the UTIAN Quality of Life Scale (UQOL)
The Utian QOL scale (UQOL) that is strongly based on perception of sense of well-being as distinct from menopausal symptoms. The UQOL contains 23 items divided into four domains: Occupational (7 items); Health (7 items); Emotional (6 items); Sexual (3 items). Total Score: 23-115. Higher scores indicate a better quality of life
Measured: at baseline, 3, and 6 months post-infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start1 Oct 2023
- Primary completion30 Dec 2025
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Sexual DysfunctionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 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 Thanh Nguyen, PhD, Study director, Vinmec Research Insitute of Stem Cell and Gene Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06726538
- Sponsor's protocol ID
- ISC.01230086
- Acronym
- IEAAMSC-W40-50
- Status last verified
- Dec 2025
- First submitted
- 2 Dec 2024
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Efficacy of Autologous, Adipose-derived Mesenchymal Stem Cell Therapy in Women Aged 40-50
- ClinicalTrials.gov ID
- NCT06726538
- Acronym / sponsor ID
- IEAAMSC-W40-50 / ISC.01230086
- Conditions
- Female Sexual Dysfunction
- Keywords
- female sexual dysfunction, sexual function impairment, adipose-derived mesenchymal stem cell therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Vinmec Research Institute of Stem Cell and Gene TechnologyUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 10 Dec 2024 (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.
Female Sexual Dysfunction (FSD) represents a critical public health challenge, significantly impacting women's physical, psychological, and social well-being. Despite its prevalence, cultural barriers in Vietnam and other Asian countries often limit awareness and research on FSD. Existing treatments, such as hormone therapy, carry risks like cardiovascular complications and cancer, emphasizing the need for innovative interventions. This study investigates FSD-related factors and evaluates the efficacy of autologous adipose-derived mesenchymal stem cell (MSC) therapy as a novel approach.
In this phase 2 clinical trial, MSCs are intravenously administered at a dose of 10^6 cells/kg. These autologous cells, which are non-immunogenic, survive for approximately 8 weeks and release growth factors and cytokines to enhance vascular supply, reduce harmful inflammation, and counteract cellular aging. The study enrolls 50 female participants randomized into two groups: Group A receives MSC infusions at months 0 and 3, while Group B acts as a control for 6 months.
Outcomes are assessed through clinical evaluations, blood tests for hormonal levels, molecular analyses, and internationally validated quality-of-life and sexual function scales. Evaluations are conducted at baseline, 3, and 6 months post-infusion. This research seeks to provide robust evidence for the safety and efficacy of MSC therapy, offering a promising alternative to conventional treatments while addressing a critical gap in women's health.
Detailed description
Female Sexual Dysfunction (FSD) is a significant public health concern. FSD can lead to various health issues and increase the risk of developing other conditions such as osteoporosis, cardiovascular diseases, and cancer. Although hormone therapy is commonly used to treat FSD, its long-term use may have adverse effects on cardiovascular health and raise the risk of cancer. Therefore, exploring new, safe, and effective treatment methods is essential. In 2015, the FDA approved the use of flibanserin (Addyi® Sprout Pharmaceuticals, USA) for premenopausal women with reduced sexual desire. However, this therapy remains controversial due to its potential side effects and limited efficacy. Current treatments for Female Sexual Dysfunction (FSD) mainly involve hormone replacement therapy, gonadotropin therapy, dietary supplements, or lifestyle modifications. While hormone therapy is commonly used to address hormonal decline in women, long-term use may lead to cardiovascular issues or cancer. Therefore, exploring psychological therapies and researching new potential treatments to meet patients' needs is essential.
Recent studies suggest that mesenchymal stem cells (MSCs) offer a safe approach to restoring hormone deficiencies. Clinical trials have investigated the use of MSC transplants to treat conditions like premature ovarian failure and ovarian cancer. Numerous trials have employed MSCs derived from bone marrow, umbilical cords, adipose tissue, or menstrual blood to address ovarian and uterine dysfunctions. Edessy et al. reported using autologous stem cells to treat 10 participants with premature ovarian failure. Following transplantation, two participants resumed menstruation within three months, one of whom became pregnant after 11 months and delivered a healthy full-term baby. Hormonal tests in the pregnant case revealed restored levels of FSH, LH, E2, and AMH to normal ranges. Although these studies are limited by small sample sizes and the lack of control groups, they highlight the potential of MSC transplantation as a treatment for FSD.
A study by Mashayekhi et al. demonstrated the safety of autologous adipose-derived mesenchymal stem cell (MSC) therapy for premature ovarian failure, with no adverse effects reported among nine participants receiving different cell doses. Menstruation resumed in two participants in both the high-dose (15x10^6 cells/kg) and lower-dose (5x10^6 and 10x10^6 cells/kg) groups, while serum FSH levels improved in four participants. Despite small sample size and lack of a control group, the study supports the safety of MSC infusion into the ovaries. Another ongoing trial (NCT01853501) aims to further investigate MSC therapy for ovarian failure, though results are pending. In Vietnam, the Vinmec Institute of Stem Cell and Gene Technology conducted a study on Female Sexual Dysfunction (FSD), using intravenous MSC infusions for 16 women. The trial reported no adverse effects, with participants reporting improved satisfaction with sexual health, though hormone levels (AMH, FSH, and E2) showed no significant changes.
This study aims to address the need for a novel and more effective approach to treating hormonal decline in women, not only improving sexual function but also enhancing their quality of life. Based on this rationale, we have decided to conduct the study titled "Investigating the efficacy of autologous, adipose-derived mesenchymal stem cell therapy for the treatment of sexual function impairment in women aged 40-50," with the following objective: Evaluate the improvement in sexual function among women aged 40-50 years who received autologous adipose-derived mesenchymal stem cell (MSC) therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MSC infusion group (Group A) | Experimental | Biological: Intravenous administration of Autologous, adipose-derived mesenchymal stem cellsThis clinical trial involves intravenous administration of MSCs at a dose of 10^6 cells/kg, offering a non-rejection approach due to the autologous nature of the cells. These cells, surviving approximately 8 weeks in the body, secrete growth factors and cytokines to nourish cells, enhance vascular supply, and mitigate harmful inflammation, thereby countering cellular aging. Fifty female participants will be randomly assigned to two groups. Group A will receive mesenchymal stem cell (MSC) infusions twice: once at baseline and a second time three months later. |
| Control group (Group B) | No intervention | –25 participants in Group B will act as controls for 6 months. |
Who may qualify
- Ages
- 40 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Women between 40 - 50 years of age and have not gone through menopause
- The last menstrual period before participating in the study at least 2 months or more
- FSH before the menopause (tested on 2nd - 7th day of the menstrual cycle): FSH ≤ 29.8 mIU/mL
- FSFI < 26.55 ± signs of decline in sexual or reproductive functions such as symptoms of premenopausal such as hot flashes, excessive sweating, headaches
- Normal liver function
Key exclusion criteria (6 listed)
- Previous surgery to remove gonads
- Diagnosed with cancer
- Had an organ transplant
- Has congenital malformations related to the gonads
- Diagnosed with chronic diseases such as diabetes, hypopituitarism, adrenal insufficiency, and blood pressure unresponsive to treatment
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 |
|---|---|---|
| Intravenous administration of Autologous, adipose-derived mesenchymal stem cellsPatients in group A will receive two infusions of autologous, adipose-derived mesenchymal stem cells at day 0 and day 90 ± 14 at a dose of 10^6 cells/kg. Autologous, adipose-derived mesenchymal stem cells used in this study were harvested from autologous fat tissue through an enzyme method and expanded using our in-house optimized serum-free and xeno-free culture under a physiological oxygen concentration of 5%. For clinical use, cells at passage 3 will be harvested in 100 mL Ringer's lactate. Therapeutic ASC products must pass the following releasing criteria: (1) negative for bacteria, fungi and mycoplasma; (2) more than 90% viability; (3) expression of more than 95% positivity for CD105, CD73, and CD90 and less than 2% positivity for CD45, CD34, CD11b, CD19, and HLA-DR; and (4) endotoxin <5 EU/kg. The patient will be infused with 1x106 cells/kg body weight within 60 minutes via the intravenous route. | Biological | MSC infusion group (Group A) |
Primary outcome
The safety of autologous, adipose-derived mesenchymal stem cell therapy based on The number of adverse events (AEs) and serious adverse events (SAEs)
Time frame: at baseline, 3, and 6 months post-infusion
Adverse Events (AEs): refer to any unfavorable or unintended signs, symptoms, or diseases that occur in a participant during a study or treatment, regardless of whether they are causally related to the intervention. Serious Adverse Events (SAEs): Events are a subset of adverse events that meet specific criteria (e.g., hospitalization, life-threatening situations) indicating a higher level of severity.
Changes in sexual functions of participants based on the Female Sexual Function Index
Time frame: at baseline, 3, and 6 months post-infusion
based on the Self-Assessment Questionnaires: the Vietnamese versions of Female Sexual Function Index (FSFI). The Female Sexual Function Index (FSFI) is a 19-item questionnaire scored on a 5-point Likert scale, designed to assess six key domains of female sexual function: desire, arousal, lubrication, orgasm, satisfaction, and pain. Total scores range from 2 to 36, with higher scores indicating better sexual function, while scores below 26.55 suggest a risk of dysfunction.
Changes in sexual functions of participants based on the AMS Diagnosing Menopause
Time frame: at baseline, 3, and 6 months post-infusion
The Self-Assessment Questionnaires: the AMS Diagnosing Menopause (AMS): the severity of problem is scored as follows score: None =0; Mild =1; Moderate =2; Severe =3. The symptoms are grouped into 4 categories, vasomotor, psychological, locomotor and urogenital. A score of 15 or over usually indicates lower sexual function
Changes in sexual functions of participants based on the UTIAN Quality of Life Scale (UQOL)
Time frame: at baseline, 3, and 6 months post-infusion
The Utian QOL scale (UQOL) that is strongly based on perception of sense of well-being as distinct from menopausal symptoms. The UQOL contains 23 items divided into four domains: Occupational (7 items); Health (7 items); Emotional (6 items); Sexual (3 items). Total Score: 23-115. Higher scores indicate a better quality of life
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 22 Jan 2026.
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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 Thanh Nguyen, PhD study director
Vinmec Research Insitute of Stem Cell and Gene Technology
2 sites 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 Intravenous administration of Autologous, adipose-derived mesenchymal stem cells in people with Female Sexual Dysfunction, run by Vinmec Research Institute of Stem Cell and Gene Technology at 2 sites 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 7 inclusion and 6 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 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The safety of autologous, adipose-derived mesenchymal stem cell therapy based on The number of adverse events (AEs) and serious adverse events (SAEs) (time frame: at baseline, 3, and 6 months post-infusion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2026.