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

This study is currently recruiting participants.
Verified September 2016 by Amit N. Patel MD MS, Amit, Patel N, M.D.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00130377
First Posted: August 15, 2005
Last Update Posted: September 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Amit N. Patel MD MS, Amit, Patel N, M.D.
August 12, 2005
August 15, 2005
September 27, 2016
August 2002
December 2020   (Final data collection date for primary outcome measure)
Safety - MACE - Death, Readmission, Reintervention [ Time Frame: 1 year ]
Heart Function change 6 month post-implant.
Complete list of historical versions of study NCT00130377 on ClinicalTrials.gov Archive Site
Not Provided
  • Toxicity
  • Optimal dose of BMPCs
Not Provided
Not Provided
 
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
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.

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

Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Cardiovascular System Diseases (& [Cardiac])
Biological: cell therapy
autologous or allogeneic cells
  • Experimental: cell therapy
    Patient receiving active biologic
    Intervention: Biological: cell therapy
  • Placebo Comparator: control
    Patient receiving placebo or standard of care
    Intervention: Biological: cell therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
December 2020
December 2020   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Amit N. Patel, MD, MS amit.patel@hsc.utah.edu
Contact: Amit N Patel, MD,MS amit.patel@hsc.utah.edu
United States
 
 
NCT00130377
0506137
Yes
Not Provided
Not Provided
Amit N. Patel MD MS, Amit, Patel N, M.D.
Amit N. Patel MD MS
Not Provided
Principal Investigator: Amit N. Patel, MD, MS University of Utah
Amit, Patel N, M.D.
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP