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

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

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00130377

Enrollment

1000

Registered

2005-08-15

Start date

2002-08-31

Completion date

2020-12-31

Last updated

2018-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular System Diseases (& [Cardiac])

Keywords

Stem Cell, Heart, Lung, Vascular, cell therapy registry

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

Interventions

BIOLOGICALcell therapy

autologous or allogeneic cells

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Safety - MACE - Death, Readmission, Reintervention	1 year

Countries

United States

Contacts

Primary ContactAmit N. Patel, MD, MS

amit.patel@hsc.utah.edu

Backup ContactAmit N Patel, MD,MS