Trial record 20 of 7519 for:    Open Studies | "Cardiovascular Diseases"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2012 by Amit, Patel N, M.D.
Sponsor:
Information provided by (Responsible Party):
Amit N. Patel MD MS, Amit, Patel N, M.D.
ClinicalTrials.gov Identifier:
NCT00130377
First received: August 12, 2005
Last updated: January 2, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Thoracic & Cardiovascular Disease
Biological: cell therapy
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cell Therapy for the Treatment of Patients With Thoracic & Cardiovascular Disease

Further study details as provided by Amit, Patel N, M.D.:

Primary Outcome Measures:
  • Safety - MACE - Death, Readmission, Reintervention [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: August 2002
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cell therapy vs control Biological: cell therapy
autologous cells
Placebo Comparator: control Biological: cell therapy
autologous cells

Detailed Description:

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

Acute myocardial infarction, Chronic Angina, Heart Failure, Peripheral Arterial Disease, Critical Limb Ischemia, Type 2 Diabetes, COPD, Asthma. Neurological disorders registry is available to specifics sites if requested.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00130377

Contacts
Contact: Amit N. Patel, MD, MS amit.patel@hsc.utah.edu
Contact: Amit N Patel, MD,MS amit.patel@hsc.utah.edu

Locations
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Amit Patel, MD MS       amit.patel@hsc.utah.edu   
Contact: Kristin Kolsch       kristin.kolsch@hsc.utah.edu   
Principal Investigator: Amit Patel, MDMS         
Sponsors and Collaborators
Amit N. Patel MD MS
Investigators
Principal Investigator: Amit N. Patel, MD, MS University of Utah
  More Information

Additional Information:
Publications:

Responsible Party: Amit N. Patel MD MS, Amit Patel, Amit, Patel N, M.D.
ClinicalTrials.gov Identifier: NCT00130377     History of Changes
Other Study ID Numbers: 0506137
Study First Received: August 12, 2005
Last Updated: January 2, 2012
Health Authority: United States: FDA/IRB

Keywords provided by Amit, Patel N, M.D.:
Stem Cell
Heart
Lung
Vascular
cell therapy registry

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014