COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004844
Recruitment Status : Unknown
Verified January 1999 by Office of Rare Diseases (ORD).
Recruitment status was:  Active, not recruiting
First Posted : February 25, 2000
Last Update Posted : June 24, 2005
University of Colorado, Denver
Information provided by:
Office of Rare Diseases (ORD)

Brief Summary:


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

Condition or disease Intervention/treatment Phase
Parkinson Disease Procedure: tissue implantation Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Study Start Date : July 1998

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


--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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004844

Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
University of Colorado, Denver
Layout table for investigator information
Study Chair: Curt R. Freed University of Colorado, Denver
Layout table for additonal information Identifier: NCT00004844    
Other Study ID Numbers: 199/13940
First Posted: February 25, 2000    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: January 1999
Keywords provided by Office of Rare Diseases (ORD):
Parkinson Disease
neurologic and psychiatric disorders
rare disease
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases