Type II Diabetes MellitusPhase 1/2NCT07495956
cfMSC Therapy for Diabetes
A Phase 1/2 study testing cfMSC therapy for diabetes in people with Type II Diabetes Mellitus, run by Shenzhen Geno-Immune Medical Institute at 1 site in China.
Trial summary
The purpose of this study is to assess the feasibility, safety and clinical efficacy of the novel clonal fetal mesenchymal stem cell (cfMSC) therapy in patients with type II diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type II Diabetes Mellitus
- What is being tested?
- cfMSC therapy for diabetes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2027to 31 Dec 2029
- Phase
- Phase 1/2
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to understand the study protocol and voluntarily sign the written informed consent form;
- A clear diagnosis of type II diabetes mellitus for more than 3 years, with poor blood glucose control under conventional treatment (HbA1c ≥ 7.5% for 3 consecutive months);
- Age 18-75 years old, with a body mass index (BMI) of 18.5-35 kg/m²;
- Fasting C-peptide level 0.3-1.5 ng/mL, indicating residual islet function;
- Karnofsky performance score (KPS) ≥ 70, with good daily living ability;
- Life expectancy > 5 years;
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- Normal liver and kidney functions (bilirubin < 1.5×ULN, ALT/AST < 2.5×ULN, creatinine < 1.5×ULN); normal blood routine (absolute neutrophil count ≥ 1.8×10^9/L, platelets ≥ 100×10^9/L);
- No serious heart, brain, lung and other important organ diseases, and stable vital signs;
- Women of childbearing age have a negative pregnancy test within 7 days before enrollment, and all subjects of childbearing age agree to take effective contraceptive measures during the study and within 1 year after the end of the study; Willing to cooperate with the whole course of follow-up and complete all examination and observation indicators.
Who cannot join
- Type 1 diabetes mellitus or other special types of diabetes;
- Severe diabetes-related complications, such as end-stage renal disease, severe proliferative retinopathy, diabetic foot with ulcer and infection, etc.;
- A history of malignant tumors within 5 years, or current suspicious malignant tumor lesions;
- HIV, hepatitis B, hepatitis C and other infectious diseases with positive pathogen indicators;
- Active autoimmune diseases, or long-term use of glucocorticoids and immunosuppressants (except for small dose hormone replacement therapy);
- A history of severe allergic reactions, or allergy to the components of the study cell preparation;
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- Pregnant or lactating women;
- Actively participating in other clinical research projects at the same time;
- Mental diseases or poor compliance that cannot cooperate with the study; Other conditions that the investigator deems unsuitable for participating in 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.
China1 site
Shenzhen Geno-immune Medical Institute
Shenzhen, Guangdong, 518000
Lung-Ji Chang, ph.D, +86 0755-86573763, c@szgimi.org
About this study
Official title: Clonal Fetal Mesenchymal Stem Cell (cfMSC) Therapy for Type II Diabetes Mellitus
The purpose of this study is to assess the feasibility, safety and clinical efficacy of the novel clonal fetal mesenchymal stem cell (cfMSC) therapy in patients with type II diabetes mellitus.
Read the detailed description
Important Regulatory Notice:
This trial record is only for global academic information registration on ClinicalTrials.gov. Neither the sponsor Beijing Meikang Jimian Biotechnology Co., Ltd. nor collaborator Shenzhen Geno-Immune Medical Institute has obtained NMPA clinical trial approval or clinical technology filing permission to carry out interventional cell therapy trials in mainland China.
ClinicalTrials.gov registration alone does not represent legal approval by Chinese health and drug regulatory authorities.
Type II diabetes mellitus is a chronic metabolic disease with progressive islet β-cell dysfunction and insulin resistance as the core pathogenesis, leading to persistent hyperglycemia and a series of microvascular and macrovascular complications. Conventional treatments including lifestyle intervention, oral hypoglycemic agents and insulin injection can only control blood glucose levels, but cannot reverse the loss and dysfunction of islet β-cells, the root cause of the disease.
At present, the clinical treatment of diabetes is mainly based on lifestyle intervention, oral hypoglycemic drugs and insulin injection, which can only control blood glucose and cannot fundamentally repair the damaged islet function and reverse the disease process. Mesenchymal stem cells have the characteristics of multi-directional differentiation potential, immune modulation, anti-inflammatory, allogeneic tolerance and paracrine effects. MSCs could have diverse sources. The fetal tissue-derived clonal MSCs (cfMSCs) have extended expansion potential, high purity and can generate rich levels of various growth factors, and can achieve high quality consistency. The cfMSCs may modulate islet-like cells' differentiation, repair the damaged islet tissue, improve insulin resistance, and regulate the abnormal immune response of the body, which is a potential new strategy for the treatment of diabetes.
This study aims to adopt intravenous infusion of cfMSCs to treat patients with type II diabetes who have poor curative effect from the conventional treatment. The goal is to evaluate the safety, feasibility and preliminary clinical efficacy of this novel therapy, and provide important clinical evidence for the clinical transformation and application of cfMSC therapy for diabetes, so as to bring new treatment options for diabetic patients.
- Conditions
- Type II Diabetes Mellitus
- Being tested
- cfMSC therapy for diabetes
- Keywords
- Clonal fetal MSCs (cfMSCs), Islet function reconstruction, Insulin resistance, Type II diabetes mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cfMSC therapy for diabetesBiological
Clonal fetal mesenchymal stem cells (cfMSCs) therapy for type II diabetes mellitus
| Study group | Role | What they receive |
|---|---|---|
| Clonal fetal mesenchymal stem cells (cfMSCs) therapy for type II diabetes mellitus | Experimental | Not described Receives: Biological: cfMSC therapy for diabetes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse events.
Determine the safety and tolerability of clonal fetal mesenchymal stem cell (cfMSC) therapy with Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: 24 weeks
Secondary outcomes (5)
Change of glycated hemoglobin (HbA1c) level.
Evaluate the improvement of long-term blood glucose control in patients, with the primary observation of the change range of HbA1c from baseline to 12 and 24 months after treatment.
Measured: 24 months
Change of daily C-peptide level.
Detect the fasting and postprandial C-peptide levels to evaluate the recovery of endogenous insulin secretion function.
Measured: 24 months
Change of daily exogenous insulin dosage.
Record the change of daily insulin dosage to evaluate the degree of insulin dependence reduction.
Measured: 24 months
Proportion of patients achieving insulin independence.
Statistically analyze the number and proportion of patients who achieve complete or partial insulin independence after treatment and maintain the state for more than 6 months.
Measured: 36 months
Incidence of diabetes-related complications.
Follow up and record the occurrence and progression of microvascular and macrovascular complications such as diabetic nephropathy, retinopathy and cardiovascular and cerebrovascular diseases.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start30 Jun 2027 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type II Diabetes MellitusStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Geno-Immune Medical Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07495956
- Sponsor's protocol ID
- GIMI-IRB-26002
- Status last verified
- Aug 2026
- First submitted
- 22 Mar 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clonal Fetal Mesenchymal Stem Cell (cfMSC) Therapy for Type II Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07495956
- Acronym / sponsor ID
- GIMI-IRB-26002
- Conditions
- Type II Diabetes Mellitus
- Keywords
- Clonal fetal MSCs (cfMSCs), Islet function reconstruction, Insulin resistance, Type II diabetes mellitus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shenzhen Geno-Immune Medical InstituteUniversity, hospital or other
- Study start
- 30 Jun 2027 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 27 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.
The purpose of this study is to assess the feasibility, safety and clinical efficacy of the novel clonal fetal mesenchymal stem cell (cfMSC) therapy in patients with type II diabetes mellitus.
Detailed description
Important Regulatory Notice:
This trial record is only for global academic information registration on ClinicalTrials.gov. Neither the sponsor Beijing Meikang Jimian Biotechnology Co., Ltd. nor collaborator Shenzhen Geno-Immune Medical Institute has obtained NMPA clinical trial approval or clinical technology filing permission to carry out interventional cell therapy trials in mainland China.
ClinicalTrials.gov registration alone does not represent legal approval by Chinese health and drug regulatory authorities.
Type II diabetes mellitus is a chronic metabolic disease with progressive islet β-cell dysfunction and insulin resistance as the core pathogenesis, leading to persistent hyperglycemia and a series of microvascular and macrovascular complications. Conventional treatments including lifestyle intervention, oral hypoglycemic agents and insulin injection can only control blood glucose levels, but cannot reverse the loss and dysfunction of islet β-cells, the root cause of the disease.
At present, the clinical treatment of diabetes is mainly based on lifestyle intervention, oral hypoglycemic drugs and insulin injection, which can only control blood glucose and cannot fundamentally repair the damaged islet function and reverse the disease process. Mesenchymal stem cells have the characteristics of multi-directional differentiation potential, immune modulation, anti-inflammatory, allogeneic tolerance and paracrine effects. MSCs could have diverse sources. The fetal tissue-derived clonal MSCs (cfMSCs) have extended expansion potential, high purity and can generate rich levels of various growth factors, and can achieve high quality consistency. The cfMSCs may modulate islet-like cells' differentiation, repair the damaged islet tissue, improve insulin resistance, and regulate the abnormal immune response of the body, which is a potential new strategy for the treatment of diabetes.
This study aims to adopt intravenous infusion of cfMSCs to treat patients with type II diabetes who have poor curative effect from the conventional treatment. The goal is to evaluate the safety, feasibility and preliminary clinical efficacy of this novel therapy, and provide important clinical evidence for the clinical transformation and application of cfMSC therapy for diabetes, so as to bring new treatment options for diabetic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clonal fetal mesenchymal stem cells (cfMSCs) therapy for type II diabetes mellitus | Experimental | Biological: cfMSC therapy for diabetes |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Ability to understand the study protocol and voluntarily sign the written informed consent form;
- A clear diagnosis of type II diabetes mellitus for more than 3 years, with poor blood glucose control under conventional treatment (HbA1c ≥ 7.5% for 3 consecutive months);
- Age 18-75 years old, with a body mass index (BMI) of 18.5-35 kg/m²;
- Fasting C-peptide level 0.3-1.5 ng/mL, indicating residual islet function;
- Karnofsky performance score (KPS) ≥ 70, with good daily living ability;
Key exclusion criteria (9 listed)
- Type 1 diabetes mellitus or other special types of diabetes;
- Severe diabetes-related complications, such as end-stage renal disease, severe proliferative retinopathy, diabetic foot with ulcer and infection, etc.;
- A history of malignant tumors within 5 years, or current suspicious malignant tumor lesions;
- HIV, hepatitis B, hepatitis C and other infectious diseases with positive pathogen indicators;
- Active autoimmune diseases, or long-term use of glucocorticoids and immunosuppressants (except for small dose hormone replacement therapy);
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 |
|---|---|---|
| cfMSC therapy for diabetesClonal fetal mesenchymal stem cells (cfMSCs) therapy for type II diabetes mellitus | Biological | Clonal fetal mesenchymal stem cells (cfMSCs) therapy for type II diabetes mellitus |
Primary outcome
Number of patients with adverse events.
Time frame: 24 weeks
Determine the safety and tolerability of clonal fetal mesenchymal stem cell (cfMSC) therapy with Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
5 secondary outcomes
Change of glycated hemoglobin (HbA1c) level.
Time frame: 24 months
Change of daily C-peptide level.
Time frame: 24 months
Change of daily exogenous insulin dosage.
Time frame: 24 months
Proportion of patients achieving insulin independence.
Time frame: 36 months
Incidence of diabetes-related complications.
Time frame: 36 months
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 27 Aug 2026.
- 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.
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 cfMSC therapy for diabetes in people with Type II Diabetes Mellitus, run by Shenzhen Geno-Immune Medical Institute at 1 site in China.
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 9 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: opening soon, as of the sponsor's last update on 27 Aug 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 China. 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?
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 Lung-Ji Chang, ph.D (+86 0755-86573763, c@szgimi.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with adverse events. (time frame: 24 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 27 Aug 2026.