Impaired Glucose ToleranceNCT06495437
Preliminary Safety and Efficacy Study of Extracellular Vesicle Infusion in the Intervention of Age-related Phenotypes With Impaired Glucose Tolerance.
A study testing Intravenous infusion of extracellular vesicle preparation derived from Wharton's jelly mesenchymal stem cells. in people with Impaired Glucose Tolerance, run by BEAUTECH.
Trial summary
The objective of this exploratory study was to evaluate the initial safety of human mesenchymal stem cell-derived extracellular vesicle infusion in an age-related phenotype with impaired glucose tolerance Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Impaired Glucose Tolerance
- What is being tested?
- Intravenous infusion of extracellular vesicle preparation derived from Wharton's jelly mesenchymal stem cells.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subjects are between 35 and 65 years old (inclusive), regardless of gender;
- The subject's body mass index (BMI) is between 20kg/m2 and 30 kg/m2;
- The subjects were assessed by the clinical expert group as having abnormal glucose tolerance (PPG 7.8-11.0mmol/L 2h postprandial);
- Subjects voluntarily participate in this clinical study and sign a written informed consent.
Who cannot join
- The subject has a severe allergy or is allergic to any component used in cell culture;
- The subject has used or is using drugs that affect glucose metabolism (such as glucocorticoids, tricyclic antidepressants, etc.) within 1 month;
- The subjects have chronic diseases such as diabetes and hypertension (very high-risk group) which have not been effectively controlled after treatment;
- Subjects with severe cardiovascular and cerebrovascular diseases: patients with a history of decompensated cardiac insufficiency (NYHA grade Ⅲ or Ⅳ), myocardial infarction or cerebral infarction, or cerebral hemorrhage within 6 months before screening;
- The subjects had abnormal liver function (ALT and/or AST≥ 2.5 times the upper limit of normal), significant abnormal renal function, male serum creatinine ≥1.5mg/dl, female serum creatinine ≥1.4mg/dl; 6, the subject's HIV antibody, hepatitis B surface antigen, hepatitis C antibody, syphilis test positive, hepatitis B virus DNA quantitative > the upper limit of normal test unit;
- 7. Subjects with other serious systemic diseases affecting the study, including malignant tumors, nervous central system, blood system, digestive system, endocrine system, respiratory system, infectious diseases, etc.; (8) Drug or alcohol abuse (subjects who consumed >2 alcoholic beverages per day or >14 alcoholic beverages per week (one alcoholic beverage is defined as 150ml of wine, 350ml of beer, or 50ml of 80% (40 proof) spirits); Or drug abusers; 9. Pregnant and lactating women; Have a pregnancy plan in the next 2 years (including the spouse's pregnancy plan); Refusal to use effective contraception; 10. Exclude intracranial lesions and early lung tumors; 11. Used stem cell (exosome) therapy or participated in stem cell (exosome) clinical researchers 3 months before screening; Clinical investigators who have participated in drugs within 3 months before screening; 12. High risk groups with Padua score ≥4 or Caprini score ≥5; 13. The subject has a history of major surgery within the past six months or is expected to have surgery within six months; 14. There are other conditions that the researcher considers inappropriate to participate in this clinical study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The objective of this exploratory study was to evaluate the initial safety of human mesenchymal stem cell-derived extracellular vesicle infusion in an age-related phenotype with impaired glucose tolerance
- Conditions
- Impaired Glucose Tolerance
- Being tested
- Intravenous infusion of extracellular vesicle preparation derived from Wharton's jelly mesenchymal stem cells.
- Keywords
- Extracellular Vesicle, Aging, Human Mesenchymal Stem Cells, impaired glucose tolerance
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous infusion of extracellular vesicle preparation derived from Wharton's jelly mesenchymal stem cells.Biological
The trial protocol includes a 3-week screening period and a 12-week study period after enrollment. The specific trial protocol is detailed in the figure above. Cell-derived extracellular vesicle formulation will be administered at week 0, with central visits conducted during the administration period. Central visits will also be conducted at weeks 1, 4, and 12 post-administration, with a phone visit at week 8. The entire study will last for 12 weeks. Following the final follow-up visit, further observation of the intervention's effects and safety will continue for an additional 3 months. During this 3-month period, there will be no artificial intervention or restriction on the medication and biological methods for the participants in each group.
| Study group | Role | What they receive |
|---|---|---|
| single arm study | Experimental | Subjects who met the inclusion criteria were intravenously infused with 100ml extracellular vesicles derived from umbilical cord mesenchymal stem cells, at a rate of 1-1.5 hours Receives: Biological: Intravenous infusion of extracellular vesicle preparation derived from Wharton's jelly mesenchymal stem cells. |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety evaluation
Incidence of adverse events from baseline to the end of 12 weeks. The frequency and frequency of adverse events (including injection site reactions) were analyzed. The number of cases and cases of adverse events, adverse reactions, AES leading to fall off, SAE, aes of different severity, AES leading to death were calculated respectively, and a detailed list was provided. The incidence rate was calculated using the number of people in each safety dataset as the denominator, and if necessary, Chi-square test or Fisher exact probability method was used for inter-group comparison.
Measured: 0-12 weeks
Secondary outcomes (6)
Effectiveness evaluation
glycated hemoglobin -1
Measured: 0-12 weeks
Effectiveness evaluation
endocrine hormones (gonadal hexa, DHEA, IGF-1)
Measured: 0-12 weeks
Effectiveness evaluation
blood glucose level
Measured: 0-12 weeks
Effectiveness evaluation
insulin secretion index
Measured: 0-12 weeks
Effectiveness evaluation
HOMA-β indexes
Measured: 0-12 weeks
Effectiveness evaluation
HOMA-IR indexes
Measured: 0-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start1 Aug 2024 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impaired Glucose ToleranceStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BEAUTECH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06495437
- Sponsor's protocol ID
- 91469002MA5RCDY83W
- Status last verified
- Jul 2024
- First submitted
- 13 Jun 2024
- Last updated
- 19 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Safety and Efficacy Study of Extracellular Vesicle Infusion in the Intervention of Age-related Phenotypes With Impaired Glucose Tolerance.
- ClinicalTrials.gov ID
- NCT06495437
- Acronym / sponsor ID
- 91469002MA5RCDY83W
- Conditions
- Impaired Glucose Tolerance
- Keywords
- Extracellular Vesicle, Aging, Human Mesenchymal Stem Cells, impaired glucose tolerance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- BEAUTECHIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Jul 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.
The objective of this exploratory study was to evaluate the initial safety of human mesenchymal stem cell-derived extracellular vesicle infusion in an age-related phenotype with impaired glucose tolerance
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm study | Experimental | Biological: Intravenous infusion of extracellular vesicle preparation derived from Wharton's jelly mesenchymal stem cells.Subjects who met the inclusion criteria were intravenously infused with 100ml extracellular vesicles derived from umbilical cord mesenchymal stem cells, at a rate of 1-1.5 hours |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The subjects are between 35 and 65 years old (inclusive), regardless of gender;
- The subject's body mass index (BMI) is between 20kg/m2 and 30 kg/m2;
- The subjects were assessed by the clinical expert group as having abnormal glucose tolerance (PPG 7.8-11.0mmol/L 2h postprandial);
- Subjects voluntarily participate in this clinical study and sign a written informed consent.
Key exclusion criteria (6 listed)
- The subject has a severe allergy or is allergic to any component used in cell culture;
- The subject has used or is using drugs that affect glucose metabolism (such as glucocorticoids, tricyclic antidepressants, etc.) within 1 month;
- The subjects have chronic diseases such as diabetes and hypertension (very high-risk group) which have not been effectively controlled after treatment;
- Subjects with severe cardiovascular and cerebrovascular diseases: patients with a history of decompensated cardiac insufficiency (NYHA grade Ⅲ or Ⅳ), myocardial infarction or cerebral infarction, or cerebral hemorrhage within 6 months before screening;
- The subjects had abnormal liver function (ALT and/or AST≥ 2.5 times the upper limit of normal), significant abnormal renal function, male serum creatinine ≥1.5mg/dl, female serum creatinine ≥1.4mg/dl; 6, the subject's HIV antibody, hepatitis B surface antigen, hepatitis C antibody, syphilis test positive, hepatitis B virus DNA quantitative > the upper limit of normal test unit;
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 infusion of extracellular vesicle preparation derived from Wharton's jelly mesenchymal stem cells.The trial protocol includes a 3-week screening period and a 12-week study period after enrollment. The specific trial protocol is detailed in the figure above. Cell-derived extracellular vesicle formulation will be administered at week 0, with central visits conducted during the administration period. Central visits will also be conducted at weeks 1, 4, and 12 post-administration, with a phone visit at week 8. The entire study will last for 12 weeks. Following the final follow-up visit, further observation of the intervention's effects and safety will continue for an additional 3 months. During this 3-month period, there will be no artificial intervention or restriction on the medication and biological methods for the participants in each group. | Biological | single arm study |
Primary outcome
safety evaluation
Time frame: 0-12 weeks
Incidence of adverse events from baseline to the end of 12 weeks. The frequency and frequency of adverse events (including injection site reactions) were analyzed. The number of cases and cases of adverse events, adverse reactions, AES leading to fall off, SAE, aes of different severity, AES leading to death were calculated respectively, and a detailed list was provided. The incidence rate was calculated using the number of people in each safety dataset as the denominator, and if necessary, Chi-square test or Fisher exact probability method was used for inter-group comparison.
6 secondary outcomes
Effectiveness evaluation
Time frame: 0-12 weeks
Effectiveness evaluation
Time frame: 0-12 weeks
Effectiveness evaluation
Time frame: 0-12 weeks
Effectiveness evaluation
Time frame: 0-12 weeks
Effectiveness evaluation
Time frame: 0-12 weeks
Effectiveness evaluation
Time frame: 0-12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Intravenous infusion of extracellular vesicle preparation derived from Wharton's jelly mesenchymal stem cells. in people with Impaired Glucose Tolerance, run by BEAUTECH.
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 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: opening soon, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pinlei Lv, master (18817821388, lvpinlei@beautech.net.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety evaluation (time frame: 0-12 weeks). 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 19 Jul 2024.