Study of Human Placenta-derived Cells (PDA001) to Evaluate the Safety and Effectiveness for Patients With Active Rheumatoid Arthritis
Public ClinicalTrials.gov record NCT01261403. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2, Randomized, Double- Blind, Placebo-controlled, Multi-center Study to Evaluate the Safety and Efficacy of Intravenous Infusion of Human Placenta-Derived Cells (PDA001) for the Treatment of Adults With Active Rheumatoid Arthritis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of the study is to assess the safety and efficacy of 2 dose groups (PDA001 versus vehicle control) in subjects with active rheumatoid Arthritis. The secondary objectives of the study are to determine the clinical response at defined visit intervals, determine the time to flare of RA symptoms and to quantify changes in inflammatory markers including C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), serum amyloid A (SAA), and IL-6.
Study identification
- NCT ID
- NCT01261403
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 26 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 30, 2010
- Primary completion
- Jan 31, 2012
- Completion
- Aug 31, 2013
- Last update posted
- Jul 21, 2020
2010 – 2013
United States locations
- U.S. sites
- 16
- U.S. states
- 11
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pinnacle Research Group | Anniston | Alabama | 36207 | — |
| Advanced Pain Research Institute | Arcadia | California | 91007 | — |
| UCLA | Los Angeles | California | 90095 | — |
| Desert Medical Advances | Palm Desert | California | 92260 | — |
| Sanitas Research | Coral Gables | Florida | 33134 | — |
| Compass Research, LLC | Orlando | Florida | 32806 | — |
| Progressive Medical Research | Port Orange | Florida | 32127 | — |
| Four Rivers Clinical Research Inc. | Paducah | Kentucky | 42003 | — |
| Arthritis and Diabetes Clinic, Inc | Monroe | Louisiana | 71203 | — |
| St. Paul Rheumatology, PA | Eagan | Minnesota | 55121 | — |
| SNS Rheumatology | Lakewood | New Jersey | 08701 | — |
| David R. Mandel, MD, Inc. | Mayfield | Ohio | 44143 | — |
| Health Research of Oklahoma | Oklahoma City | Oklahoma | 73103 | — |
| Health Research Institute | Oklahoma City | Oklahoma | 73109 | — |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | — |
| Metroplex Clinical Research Center | Dallas | Texas | 75231 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01261403, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 21, 2020 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01261403 live on ClinicalTrials.gov.