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Terminated Phase 2 Interventional

STEPS Trial - Spheramine Safety and Efficacy Study

ClinicalTrials.gov ID: NCT00206687

Public ClinicalTrials.gov record NCT00206687. 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.

ClinicalTrials.gov public records Last synced Sep 29, 2026, 11:47 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Study of the Safety, Tolerability and Efficacy of Spheramine Implanted Bilaterally Into the Postcommissural Putamen of Patients With Advanced Parkinson's Disease

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of the study is to explore the safety, tolerability and efficacy of Spheramine (cultured human retinal pigment epithelial cells on microcarriers) in Parkinson's Disease patients with advanced disease who have insufficient symptom control by optimum oral medication. Patients are randomized to receive Spheramine injections into both hemispheres or a sham surgical procedure in a ratio of 1:1. A three month pretreatment period must be completed prior to surgery. Time to endpoint is 24 months.

Study identification

NCT ID
NCT00206687
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 2
Lead sponsor
Bayer
Industry
Enrollment
71 participants

Conditions and interventions

Interventions

Biological · Procedure

Eligibility (public fields only)

Age range
30 Years to 70 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
Jan 7, 2003
Primary completion
May 13, 2012
Completion
May 13, 2012
Last update posted
Oct 30, 2024

2003 – 2012

United States locations

U.S. sites
10
U.S. states
10
U.S. cities
10
Facility City State ZIP Site status
Not listed Birmingham Alabama 35233 —
Not listed Los Angeles California 90095 —
Not listed Tampa Florida 33606 —
Not listed Atlanta Georgia 30329 —
Not listed Chicago Illinois 60612 —
Not listed Kansas City Kansas 66160 —
Not listed Boston Massachusetts 02118 —
Not listed New York New York 10029-6574 —
Not listed Philadelphia Pennsylvania 19107 —
Not listed Houston Texas 77030 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00206687, 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 Oct 30, 2024 · Synced Sep 29, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00206687 live on ClinicalTrials.gov.

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