Recruiting
Phase 2
Phase 3

Cell-Based Therapies

Sponsor:

Amit N. Patel MD MS

Code:

NCT00130377

Conditions

Cardiovascular System Diseases (& [Cardiac])

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

cell therapy

Study Details

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.

Conditions

Cardiovascular System Diseases (& [Cardiac])

Study ID

NCT00130377

Start date

Aug, 2002

Status verified date

Jan, 2018

Completion date

Dec, 2020

Anticipated

Primary completion date

Dec, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1000 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: cell therapy

Patient receiving active biologic

placebo comparator: control

Patient receiving placebo or standard of care

Interventions

cell therapy

autologous or allogeneic cells

Primary outcome measure

  • Safety - MACE - Death, Readmission, Reintervention [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Amit N. Patel, MD, MS

amit.patel@hsc.utah.edu

Amit N Patel, MD,MS

amit.patel@hsc.utah.edu

Locations

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84132

Contacts

Amit Patel, MD MS

amit.patel@hsc.utah.edu

Kristin Kolsch

kristin.kolsch@hsc.utah.edu

Principal Investigator:

Amit Patel, MDMS

More Information

Sponsor

Amit N. Patel MD MS

Last update posted

Jan 19, 2018

Last verified

Jan, 2018

Keywords

  • Stem Cell
  • Heart
  • Lung
  • Vascular
  • cell therapy registry

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Amit N. Patel MD MS on 2018-01-19.