Phase
Condition
N/ATreatment
Sham surgery
bemdaneprocel
Clinical Study ID
Ages 45-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Diagnosis of clinically established PD as defined by the International Parkinson andMovement Disorders Society
Individual of any sex ≥45 to ≤75 years of age at informed consent
Robust and clear response to DA therapy as defined by MDS-UPDRS Part III
≥4 and <12 years from time of PD diagnosis at informed consent
Must demonstrate responsiveness to levodopa therapy
Receiving medical therapy for the treatment of PD symptoms
≥2.5 hours of daily OFF-time
Vaccinated per current national guidelines or local practice for patients withaltered immunocompetence
Exclusion
Exclusion Criteria:
PD presenting with recurrent falls
Diagnosis of primary mitochondrial disorder, epilepsy, stroke, multiple sclerosis,or clinical features suggestive of a neurodegenerative disease other than PD,including multiple system atrophy, progressive supranuclear palsy, corticobasaldegeneration, or Lewy body dementia
Any current or relevant previous history of serious, severe, or unstable physical,neurological, or psychiatric illness that may interfere with study participation,participant's safety, or assessment of endpoints per investigator's judgment
History of gene therapy or cell therapy
Prior treatment with intrajejunal or subcutaneous infusion therapies for PD
Prior surgical or radiation therapy to the brain, including deep brain stimulation (DBS) and lesion therapy, or prior history of intradural spinal cord surgery
Contraindication to surgery, general anesthesia, cell therapy, immunosuppression, orother required drugs, or anything that prevents use of PET or MRI
Any active infection (including but not limited to HIV, HCV, HBV, CMV, syphilis, ortuberculosis) or condition that, in the opinion of the investigator could put theparticipant at significant risk from immunosuppression or impact the participant'sability to perform study assessments
Current or previously active malignant disease within the past 5 years
Chronic immunosuppressive therapy
Receipt of another investigational therapy within 5 half-lives of the activetreatment
Pregnancy or breastfeeding
Study Design
Study Description
Connect with a study center
NeuRA (Neuroscience Research Australia)
Randwick, New South Wales 2031
AustraliaActive - Recruiting
NeuRA (Neuroscience Research Australia)
Randwick 2208285, New South Wales 2155400 2031
AustraliaSite Not Available
Gold Coast Hospital & Health Service
Southport, Queensland 4215
AustraliaActive - Recruiting
Princess Alexandra Hospital
Woolloongabba, Queensland 4102
AustraliaActive - Recruiting
Gold Coast Hospital & Health Service
Southport 2148928, Queensland 2152274 4215
AustraliaSite Not Available
Princess Alexandra Hospital
Woolloongabba 6943568, Queensland 2152274 4102
AustraliaSite Not Available
Monash Medical Centre
Clayton, Victoria 3168
AustraliaActive - Recruiting
The Alfred Hospital
Melbourne, Victoria 3004
AustraliaActive - Recruiting
The Royal Melbourne Hospital
Parkville, Victoria 3050
AustraliaActive - Recruiting
Monash Medical Centre
Clayton 2171400, Victoria 2145234 3168
AustraliaSite Not Available
The Alfred Hospital
Melbourne 2158177, Victoria 2145234 3004
AustraliaSite Not Available
The Royal Melbourne Hospital
Parkville 2153770, Victoria 2145234 3050
AustraliaSite Not Available
The University of British Columbia
Vancouver, British Columbia V6T 1Z3
CanadaActive - Recruiting
University Health Network - Toronto Western Hospital
Toronto, Ontario M5T 2S8
CanadaActive - Recruiting
University Health Network - Toronto Western Hospital
Toronto 6167865, Ontario 6093943 M5T 2S8
CanadaSite Not Available
CHUM - Centre hospitalier de l'Université de Montréal
Montreal, Quebec H2X 0C1
CanadaActive - Recruiting
CHUM - Centre hospitalier de l'Université de Montréal
Montreal 6077243, Quebec 6115047 H2X 0C1
CanadaSite Not Available
Banner Sun Health Research Institute
Sun City, Arizona 85351
United StatesActive - Recruiting
Banner Sun Health Research Institute
Sun City 5316201, Arizona 5551752 85351
United StatesSite Not Available
University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
United StatesActive - Recruiting
University of Arkansas for Medical Sciences
Little Rock 4119403, Arkansas 4099753 72205
United StatesSite Not Available
UCLA NeuroTranslational Research Center
Los Angeles, California 90095
United StatesActive - Recruiting
UCLA NeuroTranslational Research Center
Los Angeles 5368361, California 5332921 90095
United StatesSite Not Available
University of Colorado Hospital - Neurology Clinic
Aurora, Colorado 80045
United StatesActive - Recruiting
University of Colorado Hospital - Neurology Clinic
Aurora 5412347, Colorado 5417618 80045
United StatesSite Not Available
MedStar Georgetown University Hospital
Washington D.C., District of Columbia 20007
United StatesActive - Recruiting
MedStar Georgetown University Hospital
Washington D.C. 4140963, District of Columbia 4138106 20007
United StatesSite Not Available
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida 33486
United StatesSite Not Available
University of Miami Health System - Neurology
Miami, Florida 33136
United StatesActive - Recruiting
USF Parkinson's Disease and Movement Disorders Center
Tampa, Florida 33613
United StatesActive - Recruiting
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton 4148411, Florida 4155751 33486
United StatesSite Not Available
University of Miami Health System - Neurology
Miami 4164138, Florida 4155751 33136
United StatesSite Not Available
USF Parkinson's Disease and Movement Disorders Center
Tampa 4174757, Florida 4155751 33613
United StatesSite Not Available
Northwestern University
Chicago, Illinois 60611
United StatesSite Not Available
Parkinson's Disease and Movement Disorders Center at Northwestern Memorial Hospital
Chicago, Illinois 60611
United StatesActive - Recruiting
Parkinson's Disease and Movement Disorders Center at Northwestern Memorial Hospital
Chicago 4887398, Illinois 4896861 60611
United StatesSite Not Available
University of Kansas Medical Center
Kansas City, Kansas 66160-8500
United StatesActive - Recruiting
University of Kansas Medical Center
Kansas City 4273837, Kansas 4273857 66160-8500
United StatesSite Not Available
University of Louisville Hospital
Louisville, Kentucky 40202
United StatesActive - Recruiting
University of Louisville Hospital
Louisville 4299276, Kentucky 6254925 40202
United StatesSite Not Available
Johns Hopkins Hospital - Neurology
Baltimore, Maryland 21287
United StatesActive - Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United StatesActive - Recruiting
Massachusetts General Hospital
Boston, Massachusetts 02114-2696
United StatesSite Not Available
Tufts Medical Center - Neurology
Boston, Massachusetts 02111
United StatesActive - Recruiting
Beth Israel Deaconess Medical Center
Boston 4930956, Massachusetts 6254926 02215
United StatesSite Not Available
Tufts Medical Center - Neurology
Boston 4930956, Massachusetts 6254926 02111
United StatesActive - Recruiting
Michigan Clinical Research Unit - Neurology
Ann Arbor, Michigan 48109
United StatesActive - Recruiting
University of Michigan Clinical Research Unit - Neurology
Ann Arbor, Michigan 48109
United StatesActive - Recruiting
Quest Research Institute
Farmington Hills, Michigan 48334
United StatesActive - Recruiting
Michigan Clinical Research Unit - Neurology
Ann Arbor 4984247, Michigan 5001836 48109
United StatesSite Not Available
University of Michigan Clinical Research Unit - Neurology
Ann Arbor 4984247, Michigan 5001836 48109
United StatesActive - Recruiting
Quest Research Institute
Farmington Hills 4992523, Michigan 5001836 48334
United StatesSite Not Available
UBMD Neurology
Buffalo, New York 14221
United StatesActive - Recruiting
Mount Sinai West - Neurology
New York, New York 10019
United StatesActive - Recruiting
New York Presbyterian/Weill Cornell Medical Center
New York, New York 10065
United StatesActive - Recruiting
UBMD Neurology
Buffalo 5110629, New York 5128638 14221
United StatesSite Not Available
Mount Sinai West - Neurology
New York 5128581, New York 5128638 10019
United StatesSite Not Available
New York Presbyterian/Weill Cornell Medical Center
New York 5128581, New York 5128638 10065
United StatesActive - Recruiting
University of Toledo Medical Center
Toledo, Ohio 43614
United StatesActive - Recruiting
University of Toledo Medical Center
Toledo 5174035, Ohio 5165418 43614
United StatesSite Not Available
OHSU Neurology Clinic, South Waterfront
Portland, Oregon 97239
United StatesActive - Recruiting
Rhode Island Hospital
Providence, Rhode Island 02903
United StatesSite Not Available
Rhode Island Hospital - Neurology
Providence, Rhode Island 02903
United StatesActive - Recruiting
Rhode Island Hospital - Neurology
Providence 5224151, Rhode Island 5224323 02903
United StatesSite Not Available
Medical University of South Carolina, Movement Disorders Dept.
Charleston, South Carolina 29425
United StatesActive - Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United StatesActive - Recruiting
Vanderbilt University Medical Center
Nashville 4644585, Tennessee 4662168 37232
United StatesSite Not Available
UTHealth Houston Neurosciences - Texas Medical Center
Houston, Texas 77030
United StatesActive - Recruiting
UTHealth Houston Neurosciences - Texas Medical Center
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available
University of Vermont Medical Center
Burlington, Vermont 05401
United StatesActive - Recruiting
University of Vermont Medical Center
Burlington 5234372, Vermont 5242283 05401
United StatesSite Not Available
Virginia Commonwealth University
Richmond, Virginia 23284
United StatesActive - Recruiting
Virginia Commonwealth University
Richmond 4781708, Virginia 6254928 23284
United StatesSite Not Available
EvergreenHealth - Research Department
Kirkland, Washington 98034
United StatesActive - Recruiting
EvergreenHealth - Research Department
Kirkland 5799841, Washington 5815135 98034
United StatesSite Not Available

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