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

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ClinicalTrials.gov Identifier: NCT00130377
Recruitment Status : Recruiting
First Posted : August 15, 2005
Last Update Posted : January 19, 2018
Sponsor:
Information provided by (Responsible Party):
Amit N. Patel MD MS, Amit, Patel N, M.D.

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.

Condition or disease Intervention/treatment Phase
Cardiovascular System Diseases (& [Cardiac]) Biological: cell therapy Phase 2 Phase 3

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Biological Cell Therapy for the Treatment of Patients With Thoracic & Cardiovascular Disease
Study Start Date : August 2002
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Safety - MACE - Death, Readmission, Reintervention [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: August 15, 2005    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 2018

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

Additional relevant MeSH terms:
Cardiovascular Diseases