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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Biological Cell Therapy for the Treatment of Patients With Thoracic & Cardiovascular Disease

Conditions
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Cardiovascular System Diseases (& [Cardiac])

Intervention / Treatment
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* Biological: cell therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cell therapy<br>Patient receiving active biologic | Biological: cell therapy<br>* autologous or allogeneic cells<br>|
| Placebo Comparator: control<br>Patient receiving placebo or standard of care | Biological: cell therapy<br>* autologous or allogeneic cells<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - MACE - Death, Readmission, Reintervention |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stem Cell, Heart, Lung, Vascular, cell therapy registry