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
1 other identifier
interventional
1,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2002
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2002
CompletedFirst Submitted
Initial submission to the registry
August 12, 2005
CompletedFirst Posted
Study publicly available on registry
August 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedJanuary 19, 2018
January 1, 2018
18.3 years
August 12, 2005
January 17, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety - MACE - Death, Readmission, Reintervention
1 year
Study Arms (2)
cell therapy
EXPERIMENTALPatient receiving active biologic
control
PLACEBO COMPARATORPatient receiving placebo or standard of care
Interventions
Eligibility Criteria
You may qualify if:
- Age \>=18 years old
- Approved consent to be enrolled in trial/registry
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Utah
Salt Lake City, Utah, 84132, United States
Related Publications (10)
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.
PMID: 20158898BACKGROUNDBruckner 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. doi: 10.14797/mdcj-5-2-13. No abstract available.
PMID: 20073160BACKGROUNDPatel AN, Sherman W. Cardiac stem cell therapy: advances from 2008. Cell Transplant. 2009;18(3):243-4. doi: 10.3727/096368909788534960. No abstract available.
PMID: 19558772BACKGROUNDSherman 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. No abstract available.
PMID: 21999371BACKGROUNDBenoit 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.
PMID: 21951607BACKGROUNDTuma J, Fernandez-Vina 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.
PMID: 22029669BACKGROUNDPatel 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. doi: 10.1016/j.jtcvs.2005.07.056. Epub 2005 Oct 26.
PMID: 16308009RESULTPatel 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.
PMID: 26217065RESULTPatel 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.
PMID: 25834975RESULTPatel 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.
PMID: 27068030DERIVED
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amit N. Patel, MD, MS
University of Utah
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Amit Patel
Study Record Dates
First Submitted
August 12, 2005
First Posted
August 15, 2005
Study Start
August 1, 2002
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
January 19, 2018
Record last verified: 2018-01