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

NCT02552277 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2022-02-02

No results posted yet for this study

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).

Conditions

  • Diabetic Nephropathies
  • Peripheral Nervous System Diseases

Interventions

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.

Sponsors & Collaborators

  • Celularity Incorporated

    lead INDUSTRY

Principal Investigators

  • Sharmila Koppisetti · Celularity Incorporated

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-27
Primary Completion
2017-03-07
Completion
2017-10-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02552277 on ClinicalTrials.gov