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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by Amit, Patel N, M.D.
Information provided by (Responsible Party):
Amit N. Patel MD MS, Amit, Patel N, M.D.
ClinicalTrials.gov Identifier:
First received: August 12, 2005
Last updated: November 24, 2015
Last verified: November 2015
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
Cardiovascular System Diseases (& [Cardiac])
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: Biological 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
Patient receiving active biologic
Biological: cell therapy
autologous or allogeneic cells
Placebo Comparator: control
Patient receiving placebo or standard of care
Biological: cell therapy
autologous or allogeneic cells

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


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

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

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

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
Principal Investigator: Amit N. Patel, MD, MS University of Utah
  More Information


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: November 24, 2015
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 27, 2016