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A Prospective Study on Induced Pluripotent Stem Cell-Derived Exosomes for the Treatment of Diabetic Peripheral Neuropathy

A Prospective Study on Induced Pluripotent Stem Cell-Derived Exosomes for the Treatment of Diabetic Peripheral Neuropathy

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108862
Enrollment
Unknown
Registered
2025-09-08
Start date
2025-09-08
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Diabetic Peripheral Neuropathy

Interventions

Intervention group:Local injection of exosomes using a needle-free injector, administered twice per week for a duration of 2 months.
Control group:Local injection of normal saline using a needle-free injector, administered twice per week for a duration of 2 months.

Sponsors

Beijing Hospital, National Center of Gerontology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1 Aged 18–70 years; 2 Diagnosed with type 2 diabetes mellitus; 3 Poor response to one or more medications for diabetic peripheral neuropathy, 4 A significant reduction in nerve conduction velocity (NCV); 5 HbA1c <= 9% within 3 months prior to enrollment.

Exclusion criteria

Exclusion criteria: 1 Presence of hemorrhagic disorders; 2 Use of anticoagulant medications; 3 Severe skin lesions at the injection site; 4 Participation in other clinical trials; 5 Use of medications affecting nervous system function within the past 3 months; 6 History of severe hepatic or renal insufficiency, cardiovascular disease, or other systemic diseases; 7 Previous exposure to radiotherapy or chemotherapy.

Design outcomes

Primary

MeasureTime frame
Nerve Conduction Velocity (NCV);

Countries

China

Contacts

Public ContactQi Pan

Beijing Hospital, National Center of Gerontology

panqi621@126.com+86 136 8151 0924

Outcome results

None listed

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