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

This study is currently recruiting participants.
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

August 12, 2005
January 2, 2012
August 2002
December 2020   (final data collection date for primary outcome measure)
Safety - MACE - Death, Readmission, Reintervention [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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 Cell Therapy: ClinicalCellRegistry.Com
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, Peripheral Arterial Disease, Critical Limb Ischemia, Type 2 Diabetes, COPD, Asthma. Neurological disorders registry is available to specifics sites if requested.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Thoracic & Cardiovascular Disease
Biological: cell therapy
autologous cells
  • Experimental: cell therapy vs control
    Intervention: Biological: cell therapy
  • Placebo Comparator: control
    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
Both
18 Years and older
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
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.
January 2012

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