Type2 DiabetesEarly Phase 1NCT03658655
Stem Cells From Human Exfoliated Teeth in Treatment of Type 2 Diabetes
A Early Phase 1 study testing Stem Cells From Human Exfoliated Teeth in people with Type2 Diabetes, run by CAR-T (Shanghai) Biotechnology Co., Ltd. at 1 site in China.
Trial summary
To evaluate the safety and efficacy of Stem Cells From Human Exfoliated Teethtransplantation in patients with type 2 diabetes to provides scientific basis for further clinical studies to verify the safety and efficacy of type 2 diabetes.On the basis of maintaining the original treatment, intravenous drip of Stem Cells… Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- Stem Cells From Human Exfoliated Teeth
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2018to 30 Nov 2019
- Phase
- Early Phase 1
- 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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be able to understand the purpose of clinical trial, voluntarily participate in and sign the informed consent;
- Patients with type 2 diabetes WHO were clearly diagnosed according to WHO diagnostic criteria with a course of over 5 years;
- Fasting blood glucose (FPG) was still 7.5-12.0mmol/L and hemoglobin a1c (HbAlc) was still 7.0-10.0% after insulin treatment or combined with oral hypoglycemic drugs; Among them, insulin has been treated for 1 year, and the number of subcutaneous injection is 2 times or more in the last 3 months, and the type and dose of oral hypoglycemic drugs (including metformin only, antinylglycosidase inhibitors or insulin prolactin) have been stable and decreased for 3 months.
- Age 45 to 65 years male and female;
- Body mass index (BMI) between 20 and 30kg/m2;
- Male or Female subjects of childbearing age shall voluntarily take birth control measures from the screening date to the end of the follow-up;Urine pregnancy test was negative during screening of women of reproductive age, and serum pregnancy test was performed when necessary to exclude pregnancy.
Who cannot join
- Patients with type 1 diabetes, gestational diabetes or other special type of diabetes;
- All kinds of acute complications such as diabetic ketoacidosis and non-ketohyperosmotic syndrome were screened in the first month;
- Patients who had received other stem cell therapy before screening;
- Patients with poorly controlled hypertension had a blood pressure of 160/100mmHg during screening;
- Screening those who had taken thiazolidinedione, DDP-IV inhibitors and GLP-1 drugs within the first 3 months;
- Insulin therapy was used for less than 1 year before screening, and only subcutaneous injection was performed daily for nearly 3 months; One dose insulin;
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- Patients with pancreatic diseases, including those with acute and chronic pancreatitis and pancreatic tumors;
- Those with other malignant or suspected tumor tendencies;Or in active phase of infection (including hepatitis b or HCV);Immunodeficiency virus (HIV) positive patients;
- Patients suffering from other serious systemic diseases (such as cardiovascular system, respiratory system, digestive system, nervous system, endocrine system, genitourinary system, immune system and blood system);
- Patients with abnormal liver and kidney function, such as serum bilirubin TBIL exceeding 1.5 times of the normal upper limit, glutamate AST and ALT exceeding 2.5 times of the normal upper limit, and serum creatinine Cr exceeding 1.2 times of the normal upper limit;
- Being treated with systemic sex hormones (glucocorticoids), immunosuppressive or cytotoxic agents;
- Disabled person (blind, deaf, dumb, mentally handicapped, or physically disabled) as prescribed by law, a pregnant and lactating woman;People with mental illness;Patients who have a history of drug abuse or alcohol dependence within 5 years;
- Patients with contraindications or allergies treated in this study;
- Subjects who participated in other clinical studies within the last three months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open, One-arm, Single-center Clinical Study to Evaluate the Efficacy and Safety of Stem Cells From Human Exfoliated Teeth in the Treatment of Type 2 Diabetes
To evaluate the safety and efficacy of Stem Cells From Human Exfoliated Teethtransplantation in patients with type 2 diabetes to provides scientific basis for further clinical studies to verify the safety and efficacy of type 2 diabetes.On the basis of maintaining the original treatment, intravenous drip of Stem Cells From Human Exfoliated Teeth.
Read the detailed description
Basic treatment:
The original treatment regimen was maintained. During the study period, insulin dose could be adjusted with the change of blood glucose, while the type and dose of oral hypoglycemic drugs remained unchanged (except when side effects of drugs or insulin preparations were stopped or patients still had frequent hypoglycemia).
Stem cell therapy:
Dosage: Stem Cells From Human Exfoliated Teeth were calculated at 0.1IU/kg body weight .
Course of treatment: 3 times, respectively at the time of enrollment, 1 week after enrollment and 4 weeks after enrollment.
- Conditions
- Type2 Diabetes
- Being tested
- Stem Cells From Human Exfoliated Teeth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stem Cells From Human Exfoliated TeethBiological
Basic treatment:
The original treatment regimen will be maintained during the study period, insulin dose could be adjusted with the change of blood glucose, while the type and dose of oral hypoglycemic drugs remained unchanged (except when side effects of drugs or insulin preparations were stopped, but patients still had frequent hypoglycemia).
Stem cell therapy:
Usage: drip slowly, 50ml normal saline first, then Stem Cells From Human Exfoliated Teeth (during 60 min), then 50ml normal saline.
| Study group | Role | What they receive |
|---|---|---|
| Stem Cells From Human Exfoliated Teeth | Experimental | According to the weight of 0.1IU /kg with Stem Cells From Human Exfoliated Teeth, three injections will be given respectively at the time of enrollment, one week and four weeks after enrollment. Receives: Biological: Stem Cells From Human Exfoliated Teeth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total daily insulin
After treatment total daily insulin dose changes
Measured: 1 week
Secondary outcomes (1)
HbAlc
The proportion of patients with HbA1c < 7.0% and < 6.5%
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start1 Jun 2018
- Primary completion10 Nov 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 DiabetesStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- CAR-T (Shanghai) Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qin Huang, Doctor, Principal investigator, Changhai houspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03658655
- Sponsor's protocol ID
- KTLC001
- Status last verified
- Oct 2019
- First submitted
- 30 Aug 2018
- Last updated
- 28 Feb 2020
- Results posted
- 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 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, One-arm, Single-center Clinical Study to Evaluate the Efficacy and Safety of Stem Cells From Human Exfoliated Teeth in the Treatment of Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03658655
- Acronym / sponsor ID
- KTLC001
- Conditions
- Type2 Diabetes
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- CAR-T (Shanghai) Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 10 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 5 Sep 2018 (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.
To evaluate the safety and efficacy of Stem Cells From Human Exfoliated Teethtransplantation in patients with type 2 diabetes to provides scientific basis for further clinical studies to verify the safety and efficacy of type 2 diabetes.On the basis of maintaining the original treatment, intravenous drip of Stem Cells From Human Exfoliated Teeth.
Detailed description
Basic treatment:
The original treatment regimen was maintained. During the study period, insulin dose could be adjusted with the change of blood glucose, while the type and dose of oral hypoglycemic drugs remained unchanged (except when side effects of drugs or insulin preparations were stopped or patients still had frequent hypoglycemia).
Stem cell therapy:
Dosage: Stem Cells From Human Exfoliated Teeth were calculated at 0.1IU/kg body weight .
Course of treatment: 3 times, respectively at the time of enrollment, 1 week after enrollment and 4 weeks after enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stem Cells From Human Exfoliated Teeth | Experimental | Biological: Stem Cells From Human Exfoliated TeethAccording to the weight of 0.1IU /kg with Stem Cells From Human Exfoliated Teeth, three injections will be given respectively at the time of enrollment, one week and four weeks after enrollment. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be able to understand the purpose of clinical trial, voluntarily participate in and sign the informed consent;
- Patients with type 2 diabetes WHO were clearly diagnosed according to WHO diagnostic criteria with a course of over 5 years;
- Fasting blood glucose (FPG) was still 7.5-12.0mmol/L and hemoglobin a1c (HbAlc) was still 7.0-10.0% after insulin treatment or combined with oral hypoglycemic drugs; Among them, insulin has been treated for 1 year, and the number of subcutaneous injection is 2 times or more in the last 3 months, and the type and dose of oral hypoglycemic drugs (including metformin only, antinylglycosidase inhibitors or insulin prolactin) have been stable and decreased for 3 months.
- Age 45 to 65 years male and female;
- Body mass index (BMI) between 20 and 30kg/m2;
Key exclusion criteria (14 listed)
- Patients with type 1 diabetes, gestational diabetes or other special type of diabetes;
- All kinds of acute complications such as diabetic ketoacidosis and non-ketohyperosmotic syndrome were screened in the first month;
- Patients who had received other stem cell therapy before screening;
- Patients with poorly controlled hypertension had a blood pressure of 160/100mmHg during screening;
- Screening those who had taken thiazolidinedione, DDP-IV inhibitors and GLP-1 drugs within the first 3 months;
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 |
|---|---|---|
| Stem Cells From Human Exfoliated TeethBasic treatment: The original treatment regimen will be maintained during the study period, insulin dose could be adjusted with the change of blood glucose, while the type and dose of oral hypoglycemic drugs remained unchanged (except when side effects of drugs or insulin preparations were stopped, but patients still had frequent hypoglycemia). Stem cell therapy: Usage: drip slowly, 50ml normal saline first, then Stem Cells From Human Exfoliated Teeth (during 60 min), then 50ml normal saline. | Biological | Stem Cells From Human Exfoliated Teeth |
Primary outcome
Total daily insulin
Time frame: 1 week
After treatment total daily insulin dose changes
1 secondary outcome
HbAlc
Time frame: 1 week
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 28 Feb 2020.
- 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.
Qin Huang, Doctor principal investigator
Changhai houspital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Stem Cells From Human Exfoliated Teeth in people with Type2 Diabetes, run by CAR-T (Shanghai) Biotechnology Co., Ltd. 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 6 inclusion and 14 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 28 Feb 2020. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Total daily insulin (time frame: 1 week). 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 28 Feb 2020.