Actively Recruiting
Transplantation of Human iPS Cell-derived Dopaminergic Progenitors (CT1-DAP001) for Parkinson's Disease (Phase I/II)
Led by University of California, San Diego · Updated on 2025-01-29
7
Participants Needed
1
Research Sites
204 weeks
Total Duration
On this page
Sponsors
U
University of California, San Diego
Lead Sponsor
S
Sumitomo Pharma America, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
To evaluate the safety and efficacy of transplantation of human induced pluripotent stem cell-derived dopaminergic progenitors, CT1-DAP001, into the corpus striatum in patients with Parkinson's disease
CONDITIONS
Official Title
Transplantation of Human iPS Cell-derived Dopaminergic Progenitors (CT1-DAP001) for Parkinson's Disease (Phase I/II)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Parkinson's disease according to MDS Clinical Diagnostic Criteria (2015)
- Inadequate response to drug treatments for Parkinson's disease
- Age between 40 and 75 years at consent
- Parkinson's disease duration of at least 5 years
- Presence of both ON and OFF motor states as shown by symptom diary and MDS-UPDRS Part III
- Dyskinesia score less than 3 on MDS-UPDRS
- Hoehn and Yahr stage 2 or higher during OFF state
- Hoehn and Yahr stage 3 or lower during ON state
- L-dopa responsiveness of 30% or more without influence of other antiparkinsonian drugs
- Adequate organ function based on laboratory tests (neutrophils, platelets, liver enzymes, bilirubin, kidney function)
- Willingness to avoid pregnancy using effective birth control or surgical sterility
- Agreement to comply with protocol assessments
- Provided written informed consent (or verbal consent with authorized representative if physically unable to sign)
You will not qualify if you...
- Abnormal brain MRI indicating pathology other than Parkinson's disease
- Diagnosis of atypical parkinsonism or Parkinsonism-Plus syndrome
- Abnormal immune function or related clinical indications
- Diagnosis or high risk of major neurocognitive disorders such as dementia
- Bleeding disorders or abnormal coagulation (platelets <50 or PT/PTT >1.5x normal)
- Positive for hepatitis B surface antigen or antibodies with HBV-DNA evidence
- Positive for HIV or HTLV-1 antibodies
- Active infections like hepatitis C or syphilis
- Allergies or contraindications to tacrolimus, levodopa, carbidopa, MRI contrast, or components of study products
- Contraindications to general anesthesia
- Serious allergies to components used in study product preparation
- Concurrent serious illnesses including malignant neoplasm, epilepsy, psychiatric disorders, poorly controlled diabetes, cerebrovascular or heart disease
- History of prior malignancy within 5 years unless in remission with good prognosis
- History of epilepsy, cerebral hemorrhage, stroke, psychiatric disease, congenital long QT syndrome, or brain surgeries like pallidotomy or deep brain stimulation
- Pregnant or lactating, or unwilling to avoid pregnancy during the study
- Previous transplantation of human iPSC-derived dopaminergic progenitors
- Investigator judgment that participation is unsafe
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of California, San Diego
La Jolla, California, United States, 92037
Actively Recruiting
Research Team
C
Christian Fulinara
CONTACT
D
Donna Brusch
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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