Randomized Study of Fetal Neurotransplantation for the Treatment of Parkinson's Disease - Full Text View

Randomized Study of Fetal Neurotransplantation for the Treatment of Parkinson's Disease

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators:	National Institute of Neurological Disorders and Stroke (NINDS) University of Colorado at Denver and Health Sciences Center
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00004844

Purpose

OBJECTIVES:

I. Assess the safety and efficacy of embryonic mesencephalic dopamine cell implants into the putamen of patients with Parkinson's disease.

Condition	Intervention
Parkinson Disease	Procedure: tissue implantation

Genetics Home Reference related topics:

familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics:

Parkinson's Disease

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment:	40
Study Start Date:	July 1998

Detailed Description:

PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled study. Patients are stratified by age (over and under 60). Patients are randomized to receive either sham surgery or tissue implantation.

Embryonic tissue is prepared. While patients are awake, but sedated, bilateral incisions are made in the skin and burr holes drilled in the skull. A cannula is inserted into the brain to the posterior putamen. Implant patients receive embryonic neural tissue or sham patients have no needles penetrate the brain. After 1 year, patients who receive the sham operation in the first operation may receive embryonic neural tissue in a second operation.

Patients are followed every 4 months during the first year and every 6 months thereafter.

Eligibility

Ages Eligible for Study:	40 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Idiopathic Parkinson's disease for at least 7 years with rest tremor or bradykinesia and one of the following cardinal signs: Rigidity Flexed posture Loss of postural reflexes Freezing (motor blocks)
Continuing response to levodopa
Presence of at least one of the following intractable symptoms or signs: Intractable disabling fluctuations Intractable disabling dyskinesias Intractable "on" freezing (i.e., motor blocks that interfere with walking despite being "on"
Bilateral parkinsonism when "off" (may be asymmetry between right and left sides)
Decreased dopa uptake in the striatum

--Prior/Concurrent Therapy--

No prior brain surgery

--Patient Characteristics--

Cardiovascular: No severe cardiopulmonary disease
Neurologic: No history of strokes No neuroleptics No encephalitis No oculogyric crisis No remission No cerebellar signs No dementia (Mini-Mental state score no greater than 22) No supranuclear gaze palsy No Babinski sign No orthostatic hypotension No hydrocephalus No brain tumor No occlusive cerebrovascular disease
Pulmonary: Absolute standing pressure at least 90/60 mmHg
Other: No diabetes mellitus No exposure to toxins No other severe medical disease Hamilton Depression Scale score of less than 20 points

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004844

Sponsors and Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

University of Colorado at Denver and Health Sciences Center

Investigators


Study Chair:	Curt R. Freed	University of Colorado at Denver and Health Sciences Center

More Information

Study ID Numbers:	199/13940, UCHSC-COMIRB-9397
First Received:	February 24, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004844
Health Authority:	United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):

Parkinson Disease

neurologic and psychiatric disorders

rare disease

Study placed in the following topic categories:

Ganglion Cysts

Movement Disorders

Mental Disorders

Parkinson Disease

Basal Ganglia Diseases

Rare Diseases

Central Nervous System Diseases

Parkinsonian Disorders

Neurodegenerative Diseases

Brain Diseases

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on December 03, 2008