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NCT ID: NCT04825613 No longer available - Clinical trials for Primary Lateral Sclerosis, Adult, 1

"Individual Patient Expanded Access IND to Treat Primary Lateral Sclerosis"

Start date: n/a
Phase:
Study type: Expanded Access

This Individual Patient Expanded Access IND has been created as requested by an 83-year-old man who suffers Primary Lateral Sclerosis and for which the drugs currently approved are not providing an improvement over the progression of this disease.

NCT ID: NCT04825626 No longer available - Clinical trials for Chronic Inflammatory Demyelinating Polyneuropathy

An Expanded Access IND for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Start date: n/a
Phase:
Study type: Expanded Access

This is an Individual Patient Expanded Access IND to evaluate the safety and preliminary efficacy of autologous HB-adMSCs for treating a single patient Chronic Inflammatory Demyelinating Polyneuropathy, CIDP. The expanded access program will include a screening period of up to 28 days, a 44-week treatment period, a safety follow-up at 50, and a 52-week end-of-study visit.

NCT ID: NCT04825652 No longer available - Clinical trials for Metastatic Castration-resistant Prostate Cancer (mCRPC)

177Lu-PSMA-617 Managed Access Program for mCRPC Patients

Start date: n/a
Phase:
Study type: Expanded Access

The purpose of this Cohort Treatment Plan is to allow access to 177Lu-PSMA-617 for eligible patients diagnosed with metastatic castration-resistant prostate cancer (mCRPC). The patient's treating physician should follow the suggested treatment guidelines and comply with all local health authority regulations.

NCT ID: NCT04854369 No longer available - Prostatic Neoplasms Clinical Trials

68Ga-PSMA-11 Patients With Newly Diagnosed and Recurrent Prostate Cancer (Firefly)

Firefly
Start date: n/a
Phase:
Study type: Expanded Access

This is a prospective, Phase 2, single-center, open-label study of 68Ga-PSMA-11 PET scans in patients with biochemically recurrent prostate cancer or those diagnosed and untreated with high risk or very high risk localized prostate cancer, or oligometastatic (defined as three or fewer metastatic lesions on conventional imaging) prostate cancer (using NCCN classification for localized disease). Approximately 300 patients are planned for enrollment in this study, divided into two cohorts. Cohort A will be 225 patients in the recurrent setting. Cohort B will be 75 patients in the up-front newly diagnosed setting. After a screening period (6-week window), eligible patients will undergo baseline assessments as per the Schedule of Study Activities. Patients will receive a single dose of 68Ga-PSMA-11 and undergo a PET/CT or PET/MRI imaging study.

NCT ID: NCT04855955 No longer available - Alzheimer Disease Clinical Trials

Autologous Human Adipose-Derived Mesenchymal Stem Cells in Alzheimer's Disease

Start date: n/a
Phase:
Study type: Expanded Access

This is a single patient emergency expanded access clinical study to assess the safety of administering autologous AdMSCs to an incurable Alzheimer disease patient. The study subject will be evaluated for disease-associated severity according to symptoms, cognitive function, memory, and quality of life.

NCT ID: NCT04869501 No longer available - Cancer Clinical Trials

Expanded Access Study of TJ004309 in Patients With Advanced or Metastatic Cancer

Start date: n/a
Phase:
Study type: Expanded Access

This expanded access protocol was designed to provide TJ004309 in combination with atezolizumab to the remaining three patients with advanced or metastatic cancer who plan to continue with treatment.

NCT ID: NCT04903613 No longer available - Clinical trials for Chronic Spontaneous Urticaria

Global Managed Access Program Cohort for Ligelizumab in CSU

Start date: n/a
Phase:
Study type: Expanded Access

Global Cohort Managed Access Program (MAP) to provide access to ligelizumab (QGE031) for chronic spontaneous urticaria (CSU)

NCT ID: NCT04907175 No longer available - Clinical trials for System; Lupus Erythematosus

Individual Patient Expanded Access IND of Autologous HB-adMSCs for the Treatment of Systemic Lupus Erythematosus (SLE)

Start date: n/a
Phase:
Study type: Expanded Access

This protocol is part of an FDA Individual Patient Expanded Access IND. This study is to be conducted according to US and International Standards of Good Clinical Practice (FDA Title 21 part 312 and International Conference on Harmonization guidelines), applicable government regulations and Hope Biosciences Stem Cell Research Foundation policies and procedures.

NCT ID: NCT04907188 No longer available - Stroke Clinical Trials

Individual Patient Expanded Access IND for the Treatment of Stroke

Start date: n/a
Phase:
Study type: Expanded Access

This protocol is part of an Individual Patient Expanded Access IND. The patient is an 84-year-old male with history of Ischemic Stroke of the Left Middle Cerebral Artery causing an acute posterior left frontal cortical infarct with petechial hemorrhage and mild local mass effect without midline shift. The Stroke was due to a long-standing evolution of atrial fibrillation that provoked an embolus. The original stroke event happened on February/14/2022.

NCT ID: NCT04948398 No longer available - Clinical trials for Adenomatous Polyposis Coli

Post-Trial Access for Guselkumab in Participants With Familial Adenomatous Polyposis

Start date: n/a
Phase:
Study type: Expanded Access

The purpose of this post-trial access (PTA) program is to provide guselkumab to participants with Familial Adenomatous Polyposis (FAP) who are experiencing clinical benefit after completing 48 weeks of treatment in Study CNTO1959COR1001.