Cardiovascular System Diseases (& [Cardiac])Phase 2/3NCT00130377
Evaluation of the Treatment of Thoracic & Cardiovascular Disease With Biological Therapy: ClinicalCellRegistry.Com
A Phase 2/3 study testing cell therapy in people with Cardiovascular System Diseases (& [Cardiac]), run by Amit N. Patel MD MS at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular System Diseases (& [Cardiac])
- What is being tested?
- cell therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2002to Dec 2020
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >=18 years old
- Approved consent to be enrolled in trial/registry
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Amit N. Patel, MD, MS contact
Amit N Patel, MD,MS contact
United States1 site, 1 recruiting
- Recruiting
University of Utah
Salt Lake City, Utah, 84132
Amit Patel, MD MS, amit.patel@hsc.utah.edu
Kristin Kolsch, kristin.kolsch@hsc.utah.edu
About this study
Official title: Biological 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.
Read the 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
- Being tested
- cell therapy
- Keywords
- Stem Cell, Heart, Lung, Vascular, cell therapy registry
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cell therapyBiological
autologous or allogeneic cells
| Study group | Role | What they receive |
|---|---|---|
| cell therapy | Experimental | Patient receiving active biologic Receives: Biological: cell therapy |
| control | Placebo comparator | Patient receiving placebo or standard of care Receives: Biological: cell therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - MACE - Death, Readmission, Reintervention
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2005 (estimated)
- Study startAug 2002
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular System Diseases (& [Cardiac])Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amit N. Patel MD MS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amit N. Patel MD MS, Amit, Patel N, M.D.
- Investigators
- Amit N. Patel, MD, MS, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00130377
- Sponsor's protocol ID
- 0506137
- Status last verified
- Jan 2018
- First submitted
- 12 Aug 2005
- Last updated
- 19 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20158898Bruckner 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.
PubMed 20073160Patel AN, Sherman W. Cardiac stem cell therapy: advances from 2008. Cell Transplant. 2009;18(3):243-4. doi: 10.3727/096368909788534960. No abstract available.
PubMed 19558772Sherman 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.
PubMed 21999371Benoit 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.
PubMed 21951607Tuma 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.
PubMed 22029669Patel 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.
PubMed 16308009Patel 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.
PubMed 26217065Patel 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.
PubMed 25834975Patel 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.
PubMed 27068030
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Cell Therapy for the Treatment of Patients With Thoracic & Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT00130377
- Acronym / sponsor ID
- 0506137
- Keywords
- Stem Cell, Heart, Lung, Vascular, cell therapy registry
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Amit N. Patel MD MSUniversity, hospital or other
- Study start
- Aug 2002
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 15 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cell therapy | Experimental | Biological: cell therapyPatient receiving active biologic |
| control | Placebo comparator | Biological: cell therapyPatient receiving placebo or standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age >=18 years old
- Approved consent to be enrolled in trial/registry
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cell therapyautologous or allogeneic cells | Biological | cell therapy, control |
Primary outcome
Safety - MACE - Death, Readmission, Reintervention
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2018.
- Background: PubMed 20158898Lin 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.
- Background: PubMed 20073160Bruckner 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.
- Background: PubMed 19558772Patel AN, Sherman W. Cardiac stem cell therapy: advances from 2008. Cell Transplant. 2009;18(3):243-4. doi: 10.3727/096368909788534960. No abstract available.
- Background: PubMed 21999371Sherman 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.
- Background: PubMed 21951607Benoit 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.
- Background: PubMed 22029669Tuma 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.
- Results publication: PubMed 16308009Patel 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.
- Results publication: PubMed 26217065Patel 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.
- Results publication: PubMed 25834975Patel 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.
- Derived from this study: PubMed 27068030Patel 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amit N. Patel, MD, MS contact
Amit N Patel, MD,MS contact
Amit N. Patel, MD, MS principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing cell therapy in people with Cardiovascular System Diseases (& [Cardiac]), run by Amit N. Patel MD MS at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amit N. Patel, MD, MS (amit.patel@hsc.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety - MACE - Death, Readmission, Reintervention (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00130377, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2018.