Clinical trial NCT05294822: Autologous Regenerative Islet Transplantation for Insulin-dependent Diabetes
Official title: Autologous Regenerative Islet Transplantation for Insulin-dependent Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes
Lead sponsor: Shanghai Changzheng Hospital
Sponsor class: OTHER
First posted: 2022-03-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single-center, phase IIT clinical trial to evaluate autologous regenerative islet transplantation for insulin-dependent diabetes mellitus.

Twenty patients with insulin-dependent diabetes mellitus will be enrolled: poor blood glucose control despite intensive exogenous insulin therapy. The primary endpoint will be defined by the return to normal blood glucose control without insulin at 12 months after transplantation.


Eligibility criteria: Inclusion Criteria:

* Insulin-dependent diabetes mellitus, the specific criteria are (1 of 4-6 is sufficient).

  1. Age: 18-70 years old;
  2. History of diabetes mellitus \>1 year;
  3. Insulin-dependent and total daily insulin dose \>20 units;
  4. Poor blood glucose control despite intensive exogenous insulin therapy (or high blood glucose fluctuation, glycation \>8% );
  5. Frequent hypoglycemic episodes with unconsciousness; 6) Diabetic nephropathy, patients who need to receive kidney transplantation.

Exclusion Criteria:

* 1) Severe heart disease; 2) Severe mental disorders, poor compliance or alcohol abuse; 3) Active infection or with malignancy; 4) Weight greater than 25% of ideal weight; 5) Evidence of endogenous insulin secretion, such as type 2 diabetes; 6) Smoking; 7) During gestation or preparation for gestation.

Primary outcomes:
measure: Changes in C-peptide
timeFrame: before surgery, once a week for the first month after surgery, once a month between the second and six month after surgery, and once every 3 months afterwards, with the follow-up time of 12 months in total
measure: Changes in insulin
timeFrame: before surgery, once a week for the first month after surgery, once a month between the second and six month after surgery, and once every 3 months afterwards, with the follow-up time of 12 months in total
measure: Changes in HbA1c values
timeFrame: before surgery, once a week for the first month after surgery, once a month between the second and six month after surgery, and once every 3 months afterwards, with the follow-up time of 12 months in total
Secondary outcomes:
measure: Change in the patient's daily insulin unit requirement
timeFrame: Data will be recorded every day after the surgery until insulin treatment stops during the follow-up time of 12 months.
measure: Number of severe hypoglycemic events
timeFrame: Data will be recorded every week after the surgery during the follow-up time of 12 months.
measure: Changes in glucagon
timeFrame: before surgery, once a week for the first month after surgery, once a month between the second and six month after surgery, and once every 3 months afterwards, with the follow-up time of 12 months in total
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Changzheng Hospital
name: Hao Yin
role: PRINCIPAL_INVESTIGATOR
References: