Evaluation of the Treatment of Thoracic & Cardiovascular Disease With Biological 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
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

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

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

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

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.

Patel AN, Mittal S, Turan G, Winters AA, Henry TD, Ince H, Trehan N. REVIVE Trial: Retrograde Delivery of Autologous Bone Marrow in Patients With Heart Failure. Stem Cells Transl Med. 2015 Sep;4(9):1021-7. doi: 10.5966/sctm.2015-0070. Epub 2015 Jul 27.

Patel AN, Silva F, Winters AA. Stem cell therapy for heart failure. Heart Fail Clin. 2015 Apr;11(2):275-86. doi: 10.1016/j.hfc.2014.12.006. Review.

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. doi: 10.1186/1479-5876-8-16. 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.

Patel AN, Sherman W. Cardiac stem cell therapy: advances from 2008. Cell Transplant. 2009;18(3):243-4. doi: 10.3727/096368909788534960.

Sherman W, Mazouz C, Deans R, Patel AN. Commercialization of trials for peripheral artery disease. Cytotherapy. 2011 Nov;13(10):1157-61. doi: 10.3109/14653249.2011.620795. Review.

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. doi: 10.1186/1479-5876-9-165.

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. doi: 10.1186/1479-5876-9-183.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Patel AN, Selzman CH, Kumpati GS, McKellar SH, Bull DA. Evaluation of autologous platelet rich plasma for cardiac surgery: outcome analysis of 2000 patients. J Cardiothorac Surg. 2016 Apr 12;11(1):62. doi: 10.1186/s13019-016-0452-9.


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:	September 26, 2016
Health Authority:	United States: Food and Drug Administration

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 September 27, 2016