Frailty SyndromePhase 1NCT07462819
A Study to Evaluate the Safety and Tolerability of Intravenous Stemis™ in Elderly Subjects With Mild to Moderate Frailty Syndrome
A Phase 1 study testing Stemis™ and Normal Saline in people with Frailty Syndrome, run by Ji Yan Biomedical Co., Ltd. at 1 site in Taiwan.
Trial summary
This is a Phase 1 clinical study designed to evaluate the safety and tolerability of an investigational cell therapy product, Stemis™, in older adults with mild to moderate frailty. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Frailty Syndrome
- What is being tested?
- Stemis™ and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2026to Dec 2028
- Phase
- Phase 1
- 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects will be eligible for enrollment in the study only if they meet all the following criteria at time of Screening:
- Subjects aged ≥ 60 through ≤ 85 years old.
- Subjects with clinical diagnosis of mild to moderate FS as assessed by the Investigator with a CFS score between 4 to 6.
- Subjects will not start any new treatment for this condition during the study.
- Subjects with body weight between 40 to 90 kg.
- Subjects are willing to provide written informed consent to participate in the study after reading the informed consent form and the information provided.
Who cannot join
- Subjects meeting any of the following criteria at time of Screening will be excluded from enrollment:
- Subjects unwilling or unable to perform any of the assessments required by endpoint analysis.
- Subjects who have a diagnosis of any disabling neurologic disorder including, but not limited to: Parkinson's disease, Amyotrophic Lateral Sclerosis, multiple sclerosis, stroke or dementia.
- Subjects who have a score on the Mini-Mental State Examination (MMSE) of 24 or below.
- Subjects who have a significant comorbid medical condition(s) including, but not limited to:
- Severe kidney disease requiring hemodialysis or peritoneal dialysis.
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- Advanced liver diseases such as severe liver cirrhosis.
- Severe congestive heart failure (NYHA class 3 and 4).
- Severe pulmonary dysfunction, including severe chronic obstructive pulmonary disease stage III or IV (Gold classification)
- Subjects who have a history of deep venous thrombosis or pulmonary embolism, known hypercoagulability, or known family history of thromboembolic disease.
- Subjects who have a clinical history of malignancy within 5 years (i.e., patients with prior malignancy must be disease free for 5 years), except curatively treated basal cell carcinoma or in situ carcinomas.
- Subjects using chronic immunosuppressant therapy, including corticosteroids (> 5 mg/day of prednisone, or equivalent), or TNF-alpha antagonists.
- Subjects on chronic immunosuppressive transplant therapy.
- Subjects who have participated in another clinical study of new investigational therapies within 6 months prior to screening.
- Subjects who have received any other stem cell therapy within 12 months prior to screening.
- Subjects with known allergies or hypersensitivity to any component of the formulation and cellular therapies (i.e., penicillin or streptomycin).
- Subjects who have a history of drug or alcohol abuse within the past 3 years.
- Subjects who are known to be infected with Human Immunodeficiency Virus (HIV).
- Subjects are currently hospitalized.
- Subjects who have a significant illness as judged by principal investigator (PI) including, but not limited to:
- Psychiatric illness
- Uncontrolled hypertension or hypotension
- Unstable cardiac arrhythmia
- Active Hepatitis B, Hepatitis C infections
- Subjects who have any condition that in the opinion of the PI limits lifespan to < 1 year.
- Subjects who have any other condition that, in the opinion of the investigator, may compromise the safety or compliance of the patient or preclude successful completion of the study.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose-Escalation Study to Evaluate the Safety and Tolerability of Stemis™ Administered Intravenously in Elderly Subjects With Mild to Moderate Frailty Syndrome
This is a Phase 1 clinical study designed to evaluate the safety and tolerability of an investigational cell therapy product, Stemis™, in older adults with mild to moderate frailty.
Frailty is a condition commonly seen in older adults and may include decreased strength, slower walking speed, and reduced ability to perform daily activities. Currently, there is no specific drug treatment approved for frailty.
Read more
Stemis™ is an investigational product made from human umbilical cord-derived mesenchymal stem cells. This product has been evaluated for safety in nonclinical studies and in clinical studies for other conditions.
Approximately 12 participants between 60 and 85 years of age who have been assessed as having mild to moderate frailty will take part in this study. Participants will be randomly assigned to receive either Stemis™ or a placebo (saltwater solution). The study is double-blind, meaning that neither the participants nor the study staff will know which treatment is given.
The study treatment will be administered by intravenous infusion. During the study, participants will be closely monitored for safety, including the occurrence of adverse events, vital signs, laboratory tests, and physical examinations. In addition, assessments such as walking ability, hand grip strength, and quality-of-life questionnaires will be performed as exploratory measures.
This study is not intended to provide direct medical benefit to participants. The primary purpose of the study is to collect safety information to support future clinical research.
- Conditions
- Frailty Syndrome
- Being tested
- Stemis™, Normal Saline
- Keywords
- Frailty, Frailty Syndrome, MSC
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stemis™Biological
Stemis™ is an investigational cell therapy product administered by intravenous infusion.
Participants assigned to this intervention will receive multiple administrations of Stemis™.
The dosing frequency and administration schedule differ by cohort, and safety monitoring is conducted throughout the study.
Normal SalineDrug
Normal Saline
| Study group | Role | What they receive |
|---|---|---|
| STEMIS-1 | Experimental | Participants receive Stemis™ administered by intravenous infusion. Receives: Biological: Stemis™ |
| Saline Placebo | Placebo comparator | Participants receive placebo (normal saline) administered by intravenous infusion. Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the Maximum Feasible Dose (MFD) of Stemis™ based on the occurrence of Dose-Limiting Toxicities (DLTs)
Determination of the maximum feasible dose (MFD) of Stemis™ based on the occurrence of dose-limiting toxicities (DLTs).
A DLT is defined as any treatment-related adverse event or clinically significant laboratory abnormality meeting the protocol-specified DLT criteria and occurring within 14 days after completion of the last study intervention dose.
Measured: From first dose (Day 1) through 26 weeks after the last dose
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Number of participants experiencing one or more treatment-emergent adverse events (TEAEs) following administration of study intervention.
Measured: From first administration of study intervention through 26 weeks after the last dose
Incidence of withdrawals due to adverse events (AEs)
Number of participants who permanently discontinue study intervention or withdraw from the study due to an adverse event.
Measured: From first administration of study intervention through 26 weeks after the last dose
Number of Participants with Clinically Significant Changes in Physical Examination Findings
Number of participants with clinically significant abnormal findings on physical examination, as assessed by the investigator
Measured: From first administration of study intervention through 26 weeks after the last dose
Number of Participants with Clinically Significant Changes in Clinical Laboratory Test Results
Number of participants with clinically significant abnormal findings in clinical laboratory tests (including hematology, biochemistry, and urinalysis), as assessed by the investigator
Measured: From first administration of study intervention through 26 weeks after the last dose
Number of Participants with Clinically Significant Changes in Vital Signs
Number of participants with clinically significant abnormal findings in vital signs assessments (including blood pressure, heart rate, respiratory rate, and body temperature), as assessed by the investigator
Measured: From first administration of study intervention through 26 weeks after the last dose
Secondary outcomes (10)
Six-Minute Walk Test (6MWT)
The Six-Minute Walk Test (6MWT) measures the total distance an individual is able to walk over a period of six minutes on a hard, flat surface. Participants are instructed to walk as far as possible during the six-minute period and are allowed to self-pace and rest as needed while traversing a marked walkway. The outcome measure is the total distance walked, expressed in meters.
Measured: From baseline through 26 weeks after the last dose
Hand Grip Strength - maximum force
Hand grip strength is a measure of the maximum static force generated by the hand using a hydraulic hand dynamometer. The outcome measure is the maximum grip strength recorded, expressed in kilograms.
Measured: From baseline through 26 weeks after the last dose
Short Physical Performance Battery (SPPB) - total score
The Short Physical Performance Battery (SPPB) total score is a composite measure of physical function derived from three lower-extremity performance tests: standing balance, 4-meter walking speed, and repeated chair stands. Each component is scored on a 0-4 scale, with higher scores indicating better physical performance. The total SPPB score ranges from 0 to 12.
Measured: From baseline through 26 weeks after the last dose
Clinical Frailty Scale (CFS) - score
The Clinical Frailty Scale (CFS) is a clinician-rated measure of overall fitness or frailty based on evaluation of comorbidity, functional status, and cognition. The CFS score ranges from 1 to 9, where lower scores indicate better fitness and higher scores indicate greater frailty, with 9 representing terminal illness.
Measured: From baseline through 26 weeks after the last dose
Falls Efficacy Scale-International (FES-I) - total score
The Falls Efficacy Scale-International (FES-I) is a 16-item self-reported questionnaire that assesses concern about falling during daily activities. Each item is scored on a 4-point scale, and the total score ranges from 16 to 64, with higher scores indicating greater concern about falling.
Measured: From baseline through 26 weeks after the last dose
PROMIS Physical Function Short Form 20a - T-score
The Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 20a is a 20-item self-reported questionnaire that assesses an individual's ability to perform physical activities, ranging from activities of daily living to more demanding physical tasks. Responses are scored and converted to standardized T-scores (mean 50, standard deviation 10), with higher scores indicating better physical function.
Measured: From baseline through 26 weeks after the last dose
World Health Organization Quality of Life-BREF (WHOQOL-BREF) - domain scores
The World Health Organization Quality of Life-BREF (WHOQOL-BREF) is a 26-item questionnaire that assesses quality of life across four domains: physical health, psychological health, social relationships, and environment. Each item is rated on a 5-point Likert scale. Domain scores are calculated according to WHOQOL-BREF scoring guidelines, with higher scores indicating better quality of life.
Measured: From baseline through 26 weeks after the last dose
12-Item Short Form Health Survey (SF-12) - Physical and Mental Component Summary scores
The 12-Item Short Form Health Survey (SF-12) is a self-reported questionnaire that assesses health-related quality of life across physical and mental health domains. Results are summarized into two standardized scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Higher scores indicate better health status.
Measured: From baseline through 26 weeks after the last dose
Creatine Phosphokinase (CPK)
Change from baseline in serum creatine phosphokinase (CPK) levels as a biomarker of muscle and inflammatory status.
Measured: From baseline through 26 weeks after the last dose
N-terminal pro-B-type Natriuretic Peptide (NT-proBNP)
Change from baseline in serum N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels as a biomarker of cardiac stress.
Measured: From baseline through 26 weeks after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frailty SyndromeStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ji Yan Biomedical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- YC Biotech Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07462819
- Sponsor's protocol ID
- JY-STEMIS-007
- Status last verified
- Jan 2026
- First submitted
- 27 Jan 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose-Escalation Study to Evaluate the Safety and Tolerability of Stemis™ Administered Intravenously in Elderly Subjects With Mild to Moderate Frailty Syndrome
- ClinicalTrials.gov ID
- NCT07462819
- Acronym / sponsor ID
- JY-STEMIS-007
- Conditions
- Frailty Syndrome
- Keywords
- Frailty, Frailty Syndrome, MSC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Ji Yan Biomedical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- YC Biotech Co., Ltd.
- Study start
- Apr 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 10 Mar 2026 (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.
This is a Phase 1 clinical study designed to evaluate the safety and tolerability of an investigational cell therapy product, Stemis™, in older adults with mild to moderate frailty.
Frailty is a condition commonly seen in older adults and may include decreased strength, slower walking speed, and reduced ability to perform daily activities. Currently, there is no specific drug treatment approved for frailty.
Stemis™ is an investigational product made from human umbilical cord-derived mesenchymal stem cells. This product has been evaluated for safety in nonclinical studies and in clinical studies for other conditions.
Approximately 12 participants between 60 and 85 years of age who have been assessed as having mild to moderate frailty will take part in this study. Participants will be randomly assigned to receive either Stemis™ or a placebo (saltwater solution). The study is double-blind, meaning that neither the participants nor the study staff will know which treatment is given.
The study treatment will be administered by intravenous infusion. During the study, participants will be closely monitored for safety, including the occurrence of adverse events, vital signs, laboratory tests, and physical examinations. In addition, assessments such as walking ability, hand grip strength, and quality-of-life questionnaires will be performed as exploratory measures.
This study is not intended to provide direct medical benefit to participants. The primary purpose of the study is to collect safety information to support future clinical research.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STEMIS-1 | Experimental | Biological: Stemis™Participants receive Stemis™ administered by intravenous infusion. |
| Saline Placebo | Placebo comparator | Drug: Normal SalineParticipants receive placebo (normal saline) administered by intravenous infusion. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects will be eligible for enrollment in the study only if they meet all the following criteria at time of Screening:
- Subjects aged ≥ 60 through ≤ 85 years old.
- Subjects with clinical diagnosis of mild to moderate FS as assessed by the Investigator with a CFS score between 4 to 6.
- Subjects will not start any new treatment for this condition during the study.
- Subjects with body weight between 40 to 90 kg.
Key exclusion criteria (27 listed)
- Subjects meeting any of the following criteria at time of Screening will be excluded from enrollment:
- Subjects unwilling or unable to perform any of the assessments required by endpoint analysis.
- Subjects who have a diagnosis of any disabling neurologic disorder including, but not limited to: Parkinson's disease, Amyotrophic Lateral Sclerosis, multiple sclerosis, stroke or dementia.
- Subjects who have a score on the Mini-Mental State Examination (MMSE) of 24 or below.
- Subjects who have a significant comorbid medical condition(s) including, but not limited to:
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 |
|---|---|---|
| Stemis™Stemis™ is an investigational cell therapy product administered by intravenous infusion. Participants assigned to this intervention will receive multiple administrations of Stemis™. The dosing frequency and administration schedule differ by cohort, and safety monitoring is conducted throughout the study. | Biological | STEMIS-1 |
| Normal SalineNormal Saline | Drug | Saline Placebo |
Primary outcome
Determination of the Maximum Feasible Dose (MFD) of Stemis™ based on the occurrence of Dose-Limiting Toxicities (DLTs)
Time frame: From first dose (Day 1) through 26 weeks after the last dose
Determination of the maximum feasible dose (MFD) of Stemis™ based on the occurrence of dose-limiting toxicities (DLTs). A DLT is defined as any treatment-related adverse event or clinically significant laboratory abnormality meeting the protocol-specified DLT criteria and occurring within 14 days after completion of the last study intervention dose.
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: From first administration of study intervention through 26 weeks after the last dose
Number of participants experiencing one or more treatment-emergent adverse events (TEAEs) following administration of study intervention.
Incidence of withdrawals due to adverse events (AEs)
Time frame: From first administration of study intervention through 26 weeks after the last dose
Number of participants who permanently discontinue study intervention or withdraw from the study due to an adverse event.
Number of Participants with Clinically Significant Changes in Physical Examination Findings
Time frame: From first administration of study intervention through 26 weeks after the last dose
Number of participants with clinically significant abnormal findings on physical examination, as assessed by the investigator
Number of Participants with Clinically Significant Changes in Clinical Laboratory Test Results
Time frame: From first administration of study intervention through 26 weeks after the last dose
Number of participants with clinically significant abnormal findings in clinical laboratory tests (including hematology, biochemistry, and urinalysis), as assessed by the investigator
Number of Participants with Clinically Significant Changes in Vital Signs
Time frame: From first administration of study intervention through 26 weeks after the last dose
Number of participants with clinically significant abnormal findings in vital signs assessments (including blood pressure, heart rate, respiratory rate, and body temperature), as assessed by the investigator
10 secondary outcomes
Six-Minute Walk Test (6MWT)
Time frame: From baseline through 26 weeks after the last dose
Hand Grip Strength - maximum force
Time frame: From baseline through 26 weeks after the last dose
Short Physical Performance Battery (SPPB) - total score
Time frame: From baseline through 26 weeks after the last dose
Clinical Frailty Scale (CFS) - score
Time frame: From baseline through 26 weeks after the last dose
Falls Efficacy Scale-International (FES-I) - total score
Time frame: From baseline through 26 weeks after the last dose
PROMIS Physical Function Short Form 20a - T-score
Time frame: From baseline through 26 weeks after the last dose
World Health Organization Quality of Life-BREF (WHOQOL-BREF) - domain scores
Time frame: From baseline through 26 weeks after the last dose
12-Item Short Form Health Survey (SF-12) - Physical and Mental Component Summary scores
Time frame: From baseline through 26 weeks after the last dose
Creatine Phosphokinase (CPK)
Time frame: From baseline through 26 weeks after the last dose
N-terminal pro-B-type Natriuretic Peptide (NT-proBNP)
Time frame: From baseline through 26 weeks after the last dose
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 Mar 2026.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Stemis™ and Normal Saline in people with Frailty Syndrome, run by Ji Yan Biomedical Co., Ltd. at 1 site in Taiwan.
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 6 inclusion and 27 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 Mar 2026. 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 Taiwan. 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. Some participants in this study may receive a placebo. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Determination of the Maximum Feasible Dose (MFD) of Stemis™ based on the occurrence of Dose-Limiting Toxicities (DLTs) (time frame: From first dose (Day 1) through 26 weeks after the last dose). 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?
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 Mar 2026.