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Stem Cell Therapy

Stem Cell Therapy for Parkinson's Disease (CT1-DAP001 Trial)

Phase 1

Recruiting

Led By Joseph Ciacci, MD

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject does not have dyskinesia

Subject is in stage 2.5 or higher on the Hoehn and Yahr scale at OFF time

Must not have

Subject has an abnormal brain MRI suggestive of brain pathology other than Parkinson's disease

Subject has a clinical indication or diagnosis of abnormal immune function

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Summary

"This trial is testing whether transplanting specialized cells derived from human stem cells into the brains of patients with Parkinson's disease is safe and effective."

Who is the study for?

This trial is for individuals with Parkinson's Disease who are eligible to undergo a procedure where new cells are implanted into the brain. Specific eligibility criteria details were not provided.

What is being tested?

The study tests transplanting special cells derived from human stem cells (CT1-DAP001) into a part of the brain affected by Parkinson's, aiming to assess safety and potential improvement in symptoms.

What are the potential side effects?

Potential side effects were not detailed, but such procedures may include risks like infection, bleeding, or immune reactions. The specific side effects will be monitored closely given it's an early-phase trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I do not have uncontrolled movements.

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My Parkinson's disease is at least stage 2.5, showing more symptoms when medication wears off.

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I have been diagnosed with Parkinson's disease for 5 years or more.

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I experience clear changes in my movement abilities, as recorded in my symptom diary.

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I have been diagnosed with Parkinson's disease.

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I am between 40 and 70 years old.

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My Parkinson's disease is stage 3 or lower.

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My organ functions are within the required range according to recent tests.

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My Parkinson's symptoms improve by 30% or more with L-dopa, without other Parkinson's drugs.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My brain MRI shows signs of a condition that is not Parkinson's disease.

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My immune system does not work properly.

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I have received a transplant of dopamine-producing cells.

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I have a history of long QT syndrome.

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I have been diagnosed with atypical parkinsonism.

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I have a bleeding disorder or abnormal blood clotting.

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I have been diagnosed with dementia or am at high risk for it.

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I have tested positive for hepatitis B.

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I cannot take Tacrolimus or similar medications.

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I have used gadolinium-based contrast agents under specific conditions.

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I have other ongoing health conditions.

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I have a history of a specific disease.

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I have tested positive for the HTLV-1 antibody.

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I do not have an active infection like hepatitis C or syphilis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

ACCEPTABILITY

SAFETY

Secondary study objectives

ACCURACY

Average daily ON duration (with or without dyskinesia) and OFF duration

L-dopa equivalent dose

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single-center, open-label, uncontrolledExperimental Treatment1 Intervention

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

0 / 23Eligibility criteria met

Find a Location

Who is running the clinical trial?

Kyoto UniversityOTHER

36 Previous Clinical Trials

25,455 Total Patients Enrolled

University of California, San DiegoLead Sponsor

1,157 Previous Clinical Trials

1,571,412 Total Patients Enrolled

Sumitomo Pharma America, Inc.Industry Sponsor

242 Previous Clinical Trials

53,129 Total Patients Enrolled

~4 spots leftby Feb 2025

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