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

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Primary Purpose

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

tissue implantation

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson Disease, neurologic and psychiatric disorders, rare disease

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00004844

First Posted

February 24, 2000

Last Updated

June 23, 2005

Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborators

University of Colorado, Denver

1. Study Identification

Unique Protocol Identification Number

NCT00004844

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 1999

Overall Recruitment Status

Unknown status

Study Start Date

July 1998 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborators

University of Colorado, Denver

4. Oversight

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease

Keywords

Parkinson Disease, neurologic and psychiatric disorders, rare disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Masking

Double

Allocation

Randomized

Enrollment

40 (false)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

tissue implantation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Curt R. Freed

Organizational Affiliation

University of Colorado, Denver

Official's Role

Study Chair

Parkinson Disease

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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