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

Cardiovascular System Diseases (& [Cardiac]) Clinical Trial

Official title:

Biological Cell Therapy for the Treatment of Patients With Thoracic & Cardiovascular Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00130377
• Other study ID #: 0506137
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: August 12, 2005
• Last updated: January 17, 2018
• Start date: August 2002
• Est. completion date: December 2020

Study information

• Verified date: January 2018
• Source: Amit, Patel N, M.D.
• Contact: Amit N. Patel, MD, MS
• Email: amit.patel[@]hsc.utah.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cardiovascular System Diseases (& [Cardiac])

Intervention

Biological:
• cell therapy
autologous or allogeneic cells

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Amit N. Patel MD MS

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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- — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety - MACE - Death, Readmission, Reintervention		1 year