NCT02552277

A Efficacy and Safety Study of Intramuscular Injection of Human Placenta-Derived Cells (PDA-002) in Subjects With Diabetic Peripheral Neuropathy

A Phase 2, Randomized, Double Blind, Placebo Controlled, Dose Range Finding Study to Access the Efficacy and Safety of Intramuscular Injection of Human Placenta- Derived Cells (PDA-002) in Subjects With Diabetic Peripheral Neuropathy.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Celularity Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2, randomized, double-blind, placebo-controlled, dose range finding study in subjects who have diabetic peripheral neuropathy (DPN). The study will enroll approximately 24 subjects. Subjects will be randomized to receive one of 3 treatments: PDA-002 (3 x 10\^6 cells), PDA-002 (30 x 10\^6 cells), or placebo (vehicle control) in a 1:1:1 randomization approach. Investigational product or placebo will be administered monthly (3 administrations total on Study Days 1, 29, and 57).

Detailed description

Subjects will undergo a Screening Period (up to 28 days in duration) to determine study eligibility and baseline levels of signs and symptoms of diabetic peripheral neuropathy (DPN) will be established. Subjects will then enter a Treatment Period (6 months in duration). During the Treatment Period, subjects will be evaluated on an ongoing basis (at 8 scheduled study visits). Subjects will receive intramuscular (IM) injections of investigational product (IP) on Study Days 1, 29, and 57 as fifteen 0.30 mL injections (below the knee and above the ankle) in one lower extremity in a blinded manner. After completing the Treatment Period, subjects will enter the Follow-up Period where they will continue to be evaluated at scheduled study visits over the subsequent months. An analysis of all study data will occur after the last subject has completed Visit 9 (Month 6) and after the last scheduled study visit.

Conditions

• Diabetic Nephropathies
• Peripheral Nervous System Diseases

Interventions

Type	Name	Description
BIOLOGICAL	PDA-002	PDA-002 cells administered intramuscular (IM) on study Days 1, 29, and 57.
DRUG	Placebo	Subjects will receive placebo administered on study days 1, 29, and 57.

Timeline

• Start date: 2015-10-27
• Primary completion: 2017-03-07
• Completion: 2017-10-30
• First posted: 2015-09-17
• Last updated: 2022-02-02

Locations

7 sites across 1 country: United States