Type1diabetesEarly Phase 1NCT03912480
Stem Cells From Human Exfoliated Teeth in Treatment of Diabetic Patients With Significantly Reduced Islet Function
A Early Phase 1 study testing Stem cells from human exfoliated teeth in people with Type1diabetes, 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 teeth transplantation in patients with Islet function decreased significantly to provides scientific basis for further clinical studies to verify the safety and efficacy. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Type1diabetes
- 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
- 5 Jan 2019to 31 Mar 2021
- 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 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Understand the purpose of clinical trials, willing to participate and sign informed consent;
- Patients with type 2 diabetes are clearly diagnosed according to WHO diagnostic criteria and whose disease duration is more than 5 years, or whose disease duration of type 1 diabetes is more than 1 year;
- Islet function test (steamed bread test) : c-peptide fasting 1ng/ml, 2 hours 2ng/ml
- Insulin (with or without oral hypoglycemic therapy) and fasting blood glucose (FPG)9.0mmol/L, HbAlc 8.5; The service life of oral hypoglycemic drugs (including metformin, alpha-glucosidase inhibitors or insulin secreting agents) was more than 3 months.
- Age 25-70 years old, gender not limited;
- Body mass index (BMI) : between 19 and 28kg/m2;
- from the date of screening to the end of follow-up, male or female subjects of childbearing age will voluntarily take precautions Pregnancy; Urine pregnancy test was negative when screening women of childbearing age, and serum pregnancy test was performed when necessary to clearly exclude pregnancy.-
Who cannot join
- Patients with gestational diabetes or other special types of diabetes;
- Acute complications such as diabetic ketoacidosis and non-ketotic hyperosmolar syndrome were screened within the first month;
- Patients who have received other stem cell therapy before screening;
- Blood pressure of patients with poor blood pressure control: 160/100mmhg at the time of screening;
- Those who took thiazolidinediones, ddp-iv inhibitors and glp-1 drugs within the first 3 months were screened;
- Patients who have used insulin for less than 1 year before screening and only injected insulin subcutaneously once a day within the past 3 months;
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- Patients with pancreatic diseases, including those with acute and chronic pancreatitis and pancreatic tumors;
- Patients with other malignant tumors or suspected tumor tendency;Or in the active phase of various infections (including active stage of HBV or HCV infection);Immunodeficiency virus (HIV) positive patients;
- Patients with other serious systemic diseases (such as cardiovascular system, respiratory system, digestive system, nervous system, endocrine system, urogenital system, immune system and blood system);
- For patients with liver and kidney dysfunction, for example, serum bilirubin TBIL exceeds 1.5 times of the normal upper limit, AST and ALT exceed 2.5 times of the normal upper limit, and serum creatinine Cr exceeds 1.2 times of the normal upper limit;
- Is on systemic sex hormone (glucocorticoid), immunosuppressant or cytotoxic therapy;
- Disabled patients (blind, deaf, dumb, mentally retarded, physically disabled) as stipulated by law, pregnant women and lactating women;People suffering from mental illness;Patients who take drugs or have a history of adverse drug abuse and alcohol dependence within 5 years;
- Patients with contraindications or allergies treated in this study;
- Subjects who have participated in other clinical studies in the past 3 months.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changhai hospital
Shanghai, Shanghai Municipality
Qin Huang, Doctor, +86 13818333125, qxinyi1220@163.com
About this study
Official title: Study on the Efficacy and Safety of Stem Cells From Human Exfoliated Teeth in Treating Diabetic Patients With Significantly Reduced Islet Function
To evaluate the safety and efficacy of Stem cells from human exfoliated teeth transplantation in patients with Islet function decreased significantly to provides scientific basis for further clinical studies to verify the safety and efficacy. On the basis of maintaining the original treatment, intravenous drip of dental pulp mesenchymal stem cells.
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 0.11IU/kg body weight .
Course of treatment: 3 times, Injections were administered at enrollment, 2 weeks after enrollment, and 6 weeks after enrollment.
Note: at 1 month follow-up (V5) after the last transplantation of several cells, the subjects were still unable to discontinue insulin, and then began the second course of stem cell therapy.After the second course of treatment, the follow-up plan was resumed.
- Conditions
- Type1diabetes
- 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
Intravenous infusion of pulp mesenchymal stem cells
| Study group | Role | What they receive |
|---|---|---|
| Stem cells from human exfoliated teeth | Experimental | 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 0.11IU/kg body weight .
Course of treatment: 3 times, Injections were administered at enrollment, 2 weeks after enrollment, and 6 weeks after enrollment.
Note: at 1 month follow-up (V5) after the last transplantation of several cells, the subjects were still unable to discontinue insulin, and then began the second course of stem cell therapy.After the second course of treatment, the follow-up plan was resumed. 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 dose
change from baseline during treatment
Measured: baseline and 1,2,6 week and 2,3,6,9,12 month
glucose-c peptide release test
relative baseline change during treatment
Measured: baseline and 1,2,6 week and 2,3,6,9,12 month
Secondary outcomes (3)
Islet function
c-peptide and proinsulin
Measured: 1 year
Composite index of glycosylated hemoglobin (HbAlc) and frequency of hypoglycemia
Changes relative to baseline during treatment
Measured: 1 year
Continuous dynamic blood glucose
Changes relative to baseline during treatment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start5 Jan 2019
- Primary completion30 Dec 2020 (estimated)
- Study completion31 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1diabetesStudies 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 (estimated)
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
- NCT03912480
- Sponsor's protocol ID
- KTLC002
- Status last verified
- Apr 2019
- First submitted
- 10 Apr 2019
- Last updated
- 22 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Efficacy and Safety of Stem Cells From Human Exfoliated Teeth in Treating Diabetic Patients With Significantly Reduced Islet Function
- ClinicalTrials.gov ID
- NCT03912480
- Acronym / sponsor ID
- KTLC002
- Conditions
- Type1diabetes
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- CAR-T (Shanghai) Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Jan 2019 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 11 Apr 2019 (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 teeth transplantation in patients with Islet function decreased significantly to provides scientific basis for further clinical studies to verify the safety and efficacy. On the basis of maintaining the original treatment, intravenous drip of dental pulp mesenchymal stem cells.
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 0.11IU/kg body weight .
Course of treatment: 3 times, Injections were administered at enrollment, 2 weeks after enrollment, and 6 weeks after enrollment.
Note: at 1 month follow-up (V5) after the last transplantation of several cells, the subjects were still unable to discontinue insulin, and then began the second course of stem cell therapy.After the second course of treatment, the follow-up plan was resumed.
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 teethBasic 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 0.11IU/kg body weight . Course of treatment: 3 times, Injections were administered at enrollment, 2 weeks after enrollment, and 6 weeks after enrollment. Note: at 1 month follow-up (V5) after the last transplantation of several cells, the subjects were still unable to discontinue insulin, and then began the second course of stem cell therapy.After the second course of treatment, the follow-up plan was resumed. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Understand the purpose of clinical trials, willing to participate and sign informed consent;
- Patients with type 2 diabetes are clearly diagnosed according to WHO diagnostic criteria and whose disease duration is more than 5 years, or whose disease duration of type 1 diabetes is more than 1 year;
- Islet function test (steamed bread test) : c-peptide fasting 1ng/ml, 2 hours 2ng/ml
- Insulin (with or without oral hypoglycemic therapy) and fasting blood glucose (FPG)9.0mmol/L, HbAlc 8.5; The service life of oral hypoglycemic drugs (including metformin, alpha-glucosidase inhibitors or insulin secreting agents) was more than 3 months.
- Age 25-70 years old, gender not limited;
Key exclusion criteria (14 listed)
- Patients with gestational diabetes or other special types of diabetes;
- Acute complications such as diabetic ketoacidosis and non-ketotic hyperosmolar syndrome were screened within the first month;
- Patients who have received other stem cell therapy before screening;
- Blood pressure of patients with poor blood pressure control: 160/100mmhg at the time of screening;
- Those who took thiazolidinediones, ddp-iv inhibitors and glp-1 drugs within the first 3 months were screened;
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 teethIntravenous infusion of pulp mesenchymal stem cells | Biological | Stem cells from human exfoliated teeth |
Primary outcome
Total daily insulin dose
Time frame: baseline and 1,2,6 week and 2,3,6,9,12 month
change from baseline during treatment
glucose-c peptide release test
Time frame: baseline and 1,2,6 week and 2,3,6,9,12 month
relative baseline change during treatment
3 secondary outcomes
Islet function
Time frame: 1 year
Composite index of glycosylated hemoglobin (HbAlc) and frequency of hypoglycemia
Time frame: 1 year
Continuous dynamic blood glucose
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2019.
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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 Type1diabetes, 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 7 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: status not confirmed, as of the sponsor's last update on 22 Apr 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qin Huang, Doctor (13818333125, qxinyi1220@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total daily insulin dose (time frame: baseline and 1,2,6 week and 2,3,6,9,12 month). The study lists 2 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 Apr 2019.