Evaluation of the Treatment of Thoracic & Cardiovascular Disease With Cell Therapy: ClinicalCellRegistry.Com - Full Text View

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

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:

Related Info This link exits the ClinicalTrials.gov site

Publications:

Patel AN, Geffner L, Vina RF, Saslavsky J, Urschel HC Jr, Kormos R, Benetti F. Surgical treatment for congestive heart failure with autologous adult stem cell transplantation: a prospective randomized study. J Thorac Cardiovasc Surg. 2005 Dec;130(6):1631-8. Epub 2005 Oct 26.

Tuma J, Fernández-Viña R, Carrasco A, Castillo J, Cruz C, Carrillo A, Ercilla J, Yarleque C, Cunza J, Henry TD, Patel AN. Safety and feasibility of percutaneous retrograde coronary sinus delivery of autologous bone marrow mononuclear cell transplantation in patients with chronic refractory angina. J Transl Med. 2011 Oct 26;9:183.

Benoit E, O'Donnell TF Jr, Iafrati MD, Asher E, Bandyk DF, Hallett JW, Lumsden AB, Pearl GJ, Roddy SP, Vijayaraghavan K, Patel AN. The role of amputation as an outcome measure in cellular therapy for critical limb ischemia: implications for clinical trial design. J Transl Med. 2011 Sep 27;9:165.

Lin F, Josephs SF, Alexandrescu DT, Ramos F, Bogin V, Gammill V, Dasanu CA, De Necochea-Campion R, Patel AN, Carrier E, Koos DR. Lasers, stem cells, and COPD. J Transl Med. 2010 Feb 16;8:16. Review.

Bruckner BA, Ghodsizad A, Loebe M, Beyer E, Ramchandani M, Ruhparwar A, Karck M, Burchardt ER, Patel AN, Reardon M. Surgical stem cell therapy for advanced heart failure patients. Methodist Debakey Cardiovasc J. 2009;5(2):13-7. Review. No abstract available.

Patel AN, Sherman W. Cardiac stem cell therapy: advances from 2008. Cell Transplant. 2009;18(3):243-4. No abstract available.

Sherman W, Mazouz C, Deans R, Patel AN. Commercialization of trials for peripheral artery disease. Cytotherapy. 2011 Nov;13(10):1157-61. No abstract available.

Benoit E, O'Donnell TF Jr, Iafrati MD, Asher E, Bandyk DF, Hallett JW, Lumsden AB, Pearl GJ, Roddy SP, Vijayaraghavan K, Patel AN. The role of amputation as an outcome measure in cellular therapy for critical limb ischemia: implications for clinical trial design. J Transl Med. 2011 Sep 27;9:165.

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 May 23, 2013