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PDA001 for the Treatment of Adults With Moderate-to-Severe Crohn's Disease

NCT01155362 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-07-07

Study results available
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Summary

This Phase 2a study evaluated the efficacy, safety, and tolerability of intravenous human placenta-derived cells (PDA001) compared with placebo in adults with moderate-to-severe Crohn's disease. Three PDA001 dose levels were evaluated.

Conditions

Interventions

BIOLOGICAL

Human Placenta-Derived Cells PDA001 Intravenous Infusion

DRUG

Vehicle Control

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • Celularity Incorporated

    lead INDUSTRY

Principal Investigators

  • sharmila koppisetti, MD · Celularity Incorporated

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2012-02-29
Completion
2014-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01155362 on ClinicalTrials.gov