Evaluation of the Treatment of Thoracic & Cardiovascular Disease With Biological Therapy: ClinicalCellRegistry.Com

Amit N. Patel MD MS

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Cardiovascular System Diseases (& [Cardiac])

Treatments: Biological: cell therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00130377

0506137

Details and patient eligibility

About

This is the clinical registry of cell based therapies that is available to researchers around the world. The registry is web based. All researches must provide IRB approval to the coordinating site- University of Utah in order to obtain access to the registry. The are predetermined case report forms for cardiovascular diseases that are currently in clinical trials- including demographics, safety, and possible efficacy end-points. All investigators have access to their own data. The servers are U.S. HIPPA compliant and protected with secure back-up.

Full description

The clinical cell registry includes data on thoracic and cardiovascular diseases including:

Acute myocardial infarction, Chronic Angina, Heart Failure, Wound Healing including Sternal, Peripheral Arterial Disease, Critical Limb Ischemia, Type 2 Diabetes, COPD, Asthma. Neurological disorders registry is available to specifics sites if requested. Our own biological data at the University of Utah including co-localized data with Society of Thoracic Surgeons also is a part of this program. Cell based therapies that are autologous and allogeneic are included in the registry

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age >=18 years old
• Approved consent to be enrolled in trial/registry

Exclusion criteria

• Prior malignancy in the 5 years before treatment in this study (other than curatively treated carcinoma in-situ of the cervix or non-melanoma skin cancer)
• Inability or unwillingness to comply with the treatment protocol, follow-up, research tests, or give consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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1,000 participants in 2 patient groups, including a placebo group

cell therapy

Experimental group

Description:

Patient receiving active biologic

Treatment:

Biological: cell therapy

control

Placebo Comparator group

Description:

Patient receiving placebo or standard of care

Treatment:

Biological: cell therapy