A clinical study to Evaluate the Safety of stem cells in subjects with Type 1 diabetes

Phase 2

• Conditions: Health Condition 1: null- Subject must have a diagnosis of type 1 diabetes mellitus based on the American Diabetes Association (ADA) criteriaHealth Condition 2: E109- Type 1 diabetes mellitus without complications

• Registration Number: CTRI/2017/12/010878
• Lead Sponsor: Reliance Life Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-06-05
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Other (Terminated)
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

1.Male/female patients with age 12 to 35 years (both inclusive)

2.Subject must have a diagnosis of type 1 diabetes mellitus based on the American Diabetes Association (ADA) criteria

3.Subject must be screened between 2 to 36 weeks (approximately 9 months) from initial T1DM diagnosis

4.Patients with basal C-peptide <= 0.1 ng/ml

5.Patients or legally acceptable representative (LAR) able to understand the study procedures, the risks involved, willing to provide written informed consent and able to adhere to study schedules and requirements

Exclusion Criteria

1.Patients with history of diabetic ketoacidosis

2.Patients with evidence of retinopathy at baseline

3.Patients with unstable cardiovascular status

4.Patients with C-reactive protein (hs-CRP) >3.00 ng/ml

5.Patients with baseline hemoglobin below the lower limits of normal

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of SafetyTimepoint: 12 months

Secondary Outcome Measures

Name	Time	Method
â?¢Exogenous insulin requirement <br/ ><br>â?¢Blood glucose levels <br/ ><br>â?¢Glycosylated hemoglobin (HbA1c) levels <br/ ><br>â?¢Hypoglycemic events <br/ ><br>â?¢Change in immunological parameters <br/ ><br>Timepoint: 12 Months