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

Phase 2

• Conditions: Cardiovascular System Diseases (& [Cardiac])
• Interventions: Biological: cell therapy

• Registration Number: NCT00130377
• Lead Sponsor: Amit N. Patel MD MS

Brief Summary

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

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

Study Timeline

• Study Start: 2002-08
• Study First Submitted: 2005-08-12
• Study First Submitted QC: 2005-08-12
• Study First Posted: 2005-08-15
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-17
• Last Update Posted: 2018-01-19
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
cell therapy	cell therapy	Patient receiving active biologic
control	cell therapy	Patient receiving placebo or standard of care

Primary Outcome Measures

Name	Time	Method
Safety - MACE - Death, Readmission, Reintervention	1 year

Trial Locations

Locations (1)

University of Utah; 🇺🇸 Salt Lake City, Utah, United States