Using patients' own T cells to treat Type 1 Diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the safety and efficacy of autologous regulatory T cell therapy in patients with Type 1 Diabetes Mellitus (T1DM). The study aims to address the immune dysfunction associated with T1DM by utilizing ex vivo expanded human autologous Tregs, which are designed to restore immune tolerance to pancreatic beta cells. Participants will undergo a modified preparation protocol for Tregs, and their responses will be monitored throughout the trial. The study is conducted at The Affiliated Nanjing Drum Tower Hospital, focusing on a specific patient population aged 8 to 65 years.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Meet the diagnostic criteria of T1DM based on the 2021 version of the Chinese Guidelines for Diagnosis and Treatment of Type 1 Diabetes;
* Aged 8 to 65 years;
* At least one islet autoantibody positive and/or fasting C-peptide does not exceed 300pmol/L;
* Must be capable of providing written, signed, and dated informed consent and willing to comply with research requirements in the study.

Exclusion Criteria:

* The condition of diabetic ketoacidosis has not been controlled;
* Severe allergic constitution;
* Known or suspected tumor;
* Acute pancreatitis, and severe heart, liver, kidney, rheumatic immune, respiratory, nervous or infectious diseases.
* Suffering from gestational diabetes mellitus, single gene mutation diabetes mellitus, diabetes mellitus caused by pancreatic damage or other secondary diabetes mellitus (such as diabetes mellitus caused by Cushing's syndrome, thyroid dysfunction or acromegaly, etc.);
* Women who are pregnant or have a pregnancy plan before and after treatment, and women who are breastfeeding.
* Mental illness, alcohol or drug abuse, unable to cooperate with treatment;
* According to the judgment of the investigator, there are other clinical conditions that may endanger the safety of the subjects.

Where it's running

• The Department of Endocrinology, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Dr. Lu, MD
• Email: lujing@njglyy.com
• Phone: 0086-025-868182432

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• VV-14300: a gene therapy approach for adults with type 1 diabetes not well controlled on an automated insulin system

  This trial tests VV-14300 in adults with type 1 diabetes who aren’t reaching their blood sugar goals despite using an automated insulin delivery system.

  Recruiting Phase 1/2 Kriya Therapeutics, Inc. · Toronto and 1 other locations · NCT07831798

• New gene therapies VV-14299 and VV-14300 for adults with Type 1 Diabetes failing automated insulin delivery

  This study tests VV-14299 and VV-14300, or VV-14300 alone, in adults with long-standing Type 1 Diabetes whose blood sugar remains poorly controlled despite using an automated insulin delivery system.

  Recruiting Phase 1/2 Kriya Therapeutics, Inc. · Melbourne · NCT07829302

• Oral verapamil in newly diagnosed children and teens with type 1 diabetes

  This study tests whether taking verapamil by mouth can help preserve pancreatic beta cells and reduce insulin needs in kids and teens with recently diagnosed type 1 diabetes.

  Recruiting Phase 2/3 Ain Shams University · Cairo · NCT07804849

• Preventing device-related skin rashes in kids with type 1 diabetes using hydrocolloid vs silicone patches

  This study tests whether silicone-based or hydrocolloid patches help prevent recurring skin irritation from insulin pumps or CGMs in children and teens with type 1 diabetes.

  Recruiting Steno Diabetes Center Copenhagen · Copenhagen · NCT07767461

• AI-assisted remote insulin pump optimization for people with type 1 diabetes

  This study tests an AI-powered tool that suggests insulin pump settings for people with type 1 diabetes, with doctor-approved recommendations delivered to a mobile app.

  Recruiting The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Nanjing, Jiangsu · NCT07732777

• Near-sensor insulin delivery with CGM in people with type 1 diabetes

  A small early-feasibility study tests a dual-port insulin patch pump that includes a CGM sensor to see if delivering insulin near the sensor affects glucose readings and whether an automated control algorithm can manage glucose.

  Recruiting Early Phase 1 ClinSurge Research · Toronto, Ontario · NCT07655076

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.