[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"BlueRock Therapeutics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":88},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100588678","phase-3-a-study-to-investigate-the-efficacy-and-safety-of-bemdaneprocel-in-adults-who-have-parkinsons-disease-100588678",false,"NCT06944522","A Study to Investigate the Efficacy and Safety of Bemdaneprocel in Adults Who Have Parkinson's Disease","exPDite-2: A Phase 3 Study to Assess the Efficacy and Safety of Midbrain Dopaminergic Neuronal Cell Therapy (Bemdaneprocel) for Participants With Parkinson's Disease","exPDite-2","Inclusion Criteria:\n\n* Diagnosis of clinically established PD as defined by the International Parkinson and Movement Disorders Society\n* Individual of any sex ≥45 to ≤75 years of age at informed consent\n* Robust and clear response to DA therapy as defined by MDS-UPDRS Part III\n* ≥4 and \\\u003C12 years from time of PD diagnosis at informed consent\n* Must demonstrate responsiveness to levodopa therapy\n* Receiving medical therapy for the treatment of PD symptoms\n* ≥2.5 hours of daily OFF-time\n* Vaccinated per current national guidelines or local practice for patients with altered immunocompetence\n\nExclusion Criteria:\n\n* PD presenting with recurrent falls\n* 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, corticobasal degeneration, or Lewy body dementia\n* 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\n* History of gene therapy or cell therapy\n* Prior treatment with intrajejunal or subcutaneous infusion therapies for PD\n* Prior surgical or radiation therapy to the brain, including deep brain stimulation (DBS) and lesion therapy, or prior history of intradural spinal cord surgery\n* Contraindication to surgery, general anesthesia, cell therapy, immunosuppression, or other required drugs, or anything that prevents use of PET or MRI\n* Any active infection (including but not limited to HIV, HCV, HBV, CMV, syphilis, or tuberculosis) or condition that, in the opinion of the investigator could put the participant at significant risk from immunosuppression or impact the participant's ability to perform study assessments\n* Current or previously active malignant disease within the past 5 years\n* Chronic immunosuppressive therapy\n* Receipt of another investigational therapy within 5 half-lives of the active treatment\n* Pregnancy or breastfeeding","ALL","45 Years","75 Years",{"count":21,"type":22},102,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","Study BRT-DA01-301 is a Phase 3 multicenter, randomized, sham surgery-controlled, double-blind study to assess efficacy and safety of bemdaneprocel in approximately 102 adults with Parkinson's Disease (PD).",[28],"Parkinsons Disease (PD)",[15,30,31,32,33],"Cell Therapy","Cellular Therapy","Dopaminergic Neuronal Cell Therapy","Parkinsons Disease","RECRUITING","2026-06-04",{"date":37,"type":38},"2026-06-05","ACTUAL",{"date":40,"type":38},"2025-06-17",{"date":42,"type":22},"2032-03",{"name":44,"class":45},"BlueRock Therapeutics","INDUSTRY",40,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":61,"conditions":62,"keywords":72,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},"100576757","phase-1-a-study-to-investigate-the-safety-of-opct-001-in-adults-who-have-primary-photoreceptor-disease-clarico-100576757","NCT06789445","A Study to Investigate the Safety of OpCT-001 in Adults Who Have Primary Photoreceptor Disease (CLARICO)","A Phase 1\u002F2a Study of Subretinal Administration of OpCT-001 Photoreceptor Precursor Cells Derived From iPSCs in Patients With Primary Photoreceptor Disease","CLARICO","Key Inclusion Criteria:\n\n* Confirmed genetic diagnosis of primary photoreceptor (PR) disease\n* Best corrected visual acuity (BCVA) in the study eye at Screening for Phase 1: Logmarithm of the minimum angle of resolution (LogMAR) 3.9 to LogMAR 1.3. BCVA at Screening for Phase 2: ETDRS letter score between 20 to 60, inclusive.\n* Retinal structure examination in the study eye demonstrating regions suitable for cell administration.\n\nKey Exclusion Criteria:\n\n* Clinically relevant, active ocular inflammation or infection\n* Glaucoma or other significant optic neuropathy\n* Diabetic macular edema or diabetic retinopathy\n* Clinically significant cystoid macular edema\n* In phakic participants: Spherical equivalent refractive error of greater than 8.00 diopters myopia\n* Ocular surgery ≤3 months before Screening\n* Monocular vision (ie, no light perception in the fellow eye)\n* Currently active malignancy, or history of malignancy within 5 years before OpCT-001 administration. Exception: Basal cell carcinoma that has been definitively treated.\n* Any current and active infection (bacterial\u002Fviral\u002Ffungal) that could put the participant at risk from immunosuppression\n* History of any cell therapy, gene therapy, or retinal implant at any time\n* Previously received a bone marrow or solid organ transplant","18 Years",{"count":57,"type":22},54,[59,60],"PHASE1","PHASE2","Study OpCT-001-101 is a Phase 1\u002F2a first-in-human, multisite, 2-part interventional study to evaluate the safety, tolerability, and the effect on clinical outcomes of OpCT-001 in approximately 54 adults with primary photoreceptor (PR) disease. Phase 1 focuses on safety and features a dose-escalation design. Phase 2 is designed to gather additional safety data and assess the effect of OpCT-001 on measures of visual function, functional vision, and anatomic measures of engraftment in different clinical subgroups.",[63,64,65,66,67,68,69,70,71],"Primary Photoreceptor Disease","Retinitis Pigmentosa (RP)","Usher Syndrome","Inherited Retinal Disease (IRD)","Rod-Cone Dystrophy","Rod-Cone Disease","Retinal Degeneration","Cone-Rod Disease (C-RD)","Cone-Rod Dystrophy",[53,73,30,31,65,74,75,76,77,78],"Photoreceptor cells","Retinitis Pigmentosa","Inherited retinal disease (IRD)","Primary Photoreceptor disease (PPD)","Rod-Con Disease (R-CD)","Cone-Rose disease (C-RD)","2026-04-07",{"date":81,"type":38},"2026-04-13",{"date":83,"type":38},"2025-03-10",{"date":85,"type":22},"2030-10",{"name":44,"class":45},4,""]