The purpose of the STEPS clinical research study is to evaluate the effect and safety of Spheramine implantation in patients with Parkinson’s disease. Spheramine is a cell therapy that consists of human retinal pigment epithelial (RPE) cells attached to microscopic gelatin beads (microcarriers). The RPE cells produce L-DOPA and are believed to directly enhance brain levels of dopamine. This clinical study will enroll 68 participants with advanced Parkinson’s disease. Half of the participants will be randomly (by chance) assigned to receive Spheramine, and half will receive placebo (sham or mock surgical treatment). If Spheramine is proven to be both beneficial and safe in this study, those participants who had the placebo treatment will be offered Spheramine at the end of the trial.

Condition	Treatment or Intervention	Phase
Parkinson Disease	Procedure: Spheramine	Phase II

Further Study Details: 

Expected Total Enrollment:  68

This double-blind, randomized, placebo-controlled study will evaluate the safety and efficacy of bilateral Spheramine® implantation into the brain compared to sham surgery in patients with Parkinson’s Disease. All patients will undergo a series of pre-treatment evaluations over a 3-month period by a neurologist to confirm optimization of antiparkinsonian medication and that subjects are candidates for the study according to the inclusion and exclusion criteria. At the completion of the pre-treatment phase, eligible patients will be randomized to receive either bilateral surgical implantation of Spheramine into the postcommissural putamen of the brain or a sham surgery that does not enter the brain. The surgical procedures will be performed by a neurosurgeon located in a different city. Spheramine is a permanent implant and cannot be removed.

Following administration of Spheramine or sham surgery, subjects will return to their treating neurologist for evaluations at scheduled intervals for 2 years. Spheramine patients will be followed annually thereafter for at least 5 years from receipt of Spheramine. Placebo-treated patients will be eligible for Spheramine at the end of this trial if it is shown that Spheramine is safe and effective.

Ages Eligible for Study:  30 Years   -   70 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Male or female with idiopathic Parkinson’s disease (PD) for at least 5 years
• Insufficient control of PD symptoms or intolerable side effects
• Age 30 to 70 years, inclusive
• Hoehn and Yahr Stage III or IV in the practically defined “OFF” at Screening
• Positive response to oral dopamine medication
• Stable dose of antiparkinsonian medications
• Stable concomitant diseases or medical conditions
• No contraindications to general anesthesia or stereotactic neurosurgery
• Adequate form of birth control (as appropriate)
• Available caregiver who can contribute and provide assistance, if necessary.

Exclusion Criteria:

• Atypical parkinsonism or tremor-only symptomatology
• Severe dyskinesias
• Previous pallidotomy, Deep Brain Stimulation (DBS) surgery or other striatal or extrapyramidal brain surgery
• Current treatment with apomorphine or anticoagulants (blood thinners)
• Treatment within the last 3 months treatment with immunosuppressive medications (e.g. systemic steroids) or neuroleptic medication
• Treatment with botulinum toxin, phenol, intrathecal baclofen or any other interventional treatments for dystonia or spasticity within the previous 6 months
• Active seizure disorder, or current use of antiepileptic medications as seizure prophylaxis
• Abnormal coagulation or other significant laboratory abnormality
• Active or prior malignancy other than cutaneous basal cell carcinoma or in situ carcinoma of the uterine cervix
• Current abuse of alcohol or drugs
• Pregnancy or lactation
• Participation in another clinical trial of another investigational agent or device within the previous 3 months.

Interested Participants      866-783-7703 

Alabama
      Telephone contact for more information, Birmingham,  Alabama,  35294,  United States; Recruiting
California
      Telephone contact for more information, Los Angeles,  California,  90095,  United States; Recruiting
Florida
      Telephone contact for more information, Tampa,  Florida,  33606,  United States; Recruiting
Georgia
      Telephone contact for more information, Atlanta,  Georgia,  30329,  United States; Recruiting
Illinois
      Telephone contact for more information, Chicago,  Illinois,  60612,  United States; Recruiting
Kansas
      Telephone contact for more information, Kansas City,  Kansas,  66160,  United States; Recruiting
Massachusetts
      Telephone contact for more information, Boston,  Massachusetts,  02118,  United States; Recruiting
Texas
      Telephone contact for more information, Houston,  Texas,  77030,  United States; Recruiting

Study ID Numbers:  305405
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  April 15, 2003
ClinicalTrials.gov Identifier:  NCT00059007
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08