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

A Prospective, Randomized, Multi-Centric, Comparative, Open Label, Double arm Controlled Clinical Study to Evaluate the Safety of UCMSCs in subjects with recently diagnosed Type 1 diabetes

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/12/010878

Enrollment

Registered

2017-12-14

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: R-HSC-012: UCMSCs Control Intervention1: Standard Care of Treatment: Standard Care of Treatment for Type 1 Diabetes

Eligibility

Inclusion criteria

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 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

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

Design outcomes

Primary

Measure	Time frame
Evaluation of SafetyTimepoint: 12 months	—

Secondary

Measure	Time frame
â?¢ Exogenous insulin requirement â?¢ Blood glucose levels â?¢ Glycosylated hemoglobin (HbA1c) levels â?¢ Hypoglycemic events â?¢ Change in immunological parameters Timepoint: 12 Months	—

Countries

India

Contacts

Public ContactDrPrashant Pandya

Reliance Life Sciences Pvt. Ltd.

PRATHIBHA.SHETTY@RELBIO.COM8451811778

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026