researcher looking through microscope

UCI Alpha Clinic

The UCI Alpha Clinic conducts important cell and gene therapy clinical trials to help patients like you. As part of the California Institute for Regenerative Medicine (CIRM) and one of nine Alpha Clinics throughout the State of California, we work with other leading Institutions and Sponsors  to find new therapies using stem cell therapies.

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UCI Alpha Clinic Mission About UCI Alpha Clinic Services provided at UCI Alpha Clinic What is a clinical trial? Clinical trial disease areas at UCI Alpha Clinic UCI Alpha Clinic Infusion Center UCI Alpha Stem Cell Clinic Clinical Research Coordinator Training Program (CRCTP) Alpha Clinic Clinical Trials Investigator Training Program Resources outside of UCI Alpha Clinic

UCI Alpha Clinic Mission

The UCI Alpha Clinic aims to help accelerate cell and gene therapies at UCI and in our communities. Our goals include:

  1. Creating a center of excellence: We want to be known for finding new ways to use cell therapies to treat sickness. We use our extensive experience and collaborating with our partners to make it happen.
  2. Building strong teams: Our teams are highly trained and ready to help. We use electronic data sharing systems to speed up and translate discoveries, so we can help you quicker.
  3. Transforming therapeutics: We're using Good Manufacturing Practice (GMP) to make sure the treatments you receive are safe and effective.
  4. Teaching and sharing: We want everyone to know about the many treatments available. We'll make sure you get the right information about the safest, most effective treatments.
  5. Being helpful everywhere: We're not just here for UCI. We strive to serve as a regional, national and international resource for evidence-based best practices in cell and gene treatments.

About UCI Alpha Clinic

We’re part of CIRM, a network of top California medical centers. CIRM specializes in delivering stem and gene cell clinical trials to treat all sorts of diseases.

At the UCI Alpha Clinic:

  • We work together: We help scientists and doctors work together to share ideas and progress faster.
  • We support research: We provide everything scientists need in one place, so they can focus on finding new treatments.
  • We speed up trials: We help get new treatments to you faster by ensuring research trials happen quickly and safely.

Services provided at UCI Alpha Clinic

  • Clinical trial start-up: The UCI Alpha Clinic aims to deliver a well-organized approach to starting clinical trials.
  • Clinical Trial Agreement (CTA) budget support: We negotiate budgets quickly and accurately.
  • Funding opportunity identification: We help researchers find funding opportunities for their projects.
  • Coverage analysis: We submit and review Medicare Cost Coverage Analysis paperwork for trials.
  • Grant/contract proposal development: We find subject matter experts (SMEs) to help with grant proposals.
  • Resource for institutional knowledge and information
  • Institutional Review Board (IRB) submission analysis: We act as a liaison between UCI and stakeholders with forms and paperwork for trials.
  • Database development
  • Project management
  • Research nursing support
  • Training and outreach activities
  • Regulatory support: We help the UCI community by overseeing all stem cell research studies and managing clinical trials from start to finish. Our team guides UCI investigators through protocol applications, offers education and training and ensures compliance with FDA, ICH, GCP and University standards, as well as navigating the complexities of new IND applications.

What is a clinical trial?

A clinical trial is a medical research study in which volunteers try new medical treatments to see if they are safe and effective. Some trials look at new ways to do surgeries or test new medicines. Others aim to prevent diseases, improve quality of life or help with mental and social challenges.

By joining, you can get access to cutting-edge treatments before they are widely available. Plus, you help researchers learn more about diseases and how to treat them better. Many treatments we have today are thanks to people who joined trials in the past.

Are you considering joining a clinical trial? At the UCI branch of the UCLA-UCI Alpha Clinic, you could be eligible for some exciting opportunities.

Learn more about clinical trials and their phases

Find a regenerative cell and gene medicine clinical trial

 

Clinical trial disease areas at UCI Alpha Clinic

Our clinical trials cover a wide array of conditions, including:

Diabetes

Diabetes treatment involves injecting insulin or using an insulin pump. In the future, transplanting pancreatic islets might cure the disease. Recent studies explore using stem cells to make pancreatic islets. Embryonic stem cells could be a hopeful option for treating type 1 diabetes.

We are running a stem cell trial for type 1 diabetes, and we're excited about the potential benefits for you and others managing type 1 diabetes.

Burn wounds

UCI Health Regional Burn Center stands out as one of the nation's few burn centers and the only one in Orange County recognized by both the American College of Surgeons and the American Burn Association.

Stem cell therapies bring new hope for healing burns and wounds better.

We've run successful stem cell trials for burns and we’re excited about research that reveals how stem cells can enhance wound healing speed and quality, and even regrow skin and its parts.

Neurologic diseases

We have broad expertise in treating neurologic diseases like stroke, multiple sclerosis, Parkinson’s disease, peripheral neuropathy, and rare inherited metabolic myopathies such as Pompe disease. We use advanced therapies and test new ideas in clinical trials and have already run successful stem cell clinical trials for neurologic diseases.

Our ongoing stem cell trials include therapies for Parkinson’s disease, stroke, myasthenia gravis, Pompe disease, and critical limb ischemia.

Eye diseases

The UCI Health Gavin Herbert Eye Institute is a top eye-care center in Orange County. We provide advanced eye services, from regular check-ups to complex medical therapies and surgeries.

The UCI Alpha Clinic collaborates with different partners to offer new stem cell therapies to repair or replace damaged cells in the eye due to diseases.

Other disease areas

We are working to bring new stem cell-based clinical trials to the community for the following condition areas:

  • Spinal cord injury
  • Heart diseases
  • Kidney diseases and nephrology
  • Blood disorders
  • HIV/AIDS

UCI Alpha Clinic Infusion Center

At the infusion center, the UCI Alpha Clinic team administers cell and gene therapies in support of new clinical trials, including many first-in-human studies of the latest regenerative medicine therapies.

The infusion center is located on the UC Irvine campus on the first floor of the Gross Hall Building.

Infusion center services and features

The infusion center’s wide range of clinical and supportive care services for clinical trials include:

  • An expert team of doctors, nurses, research coordinators, schedulers, and lab staff
  • Four infusion bays designed for your comfort with high-speed Wi-Fi and individual charging stations
  • A nursing station
  • A private exam room
  • State-of-the-art monitoring equipment
  • Accessible patient parking adjacent to Gross Hall

The infusion center is part of our commitment to making clinical research more accessible and supportive for you.

UCI Alpha Stem Cell Clinic Clinical Research Coordinator Training Program (CRCTP)

If you’re interested in a career in clinical research at UCI, the Clinical Research Coordinator Training Program (CRCTP) helps build skills in clinical research. This program teaches about the duties and responsibilities of a Clinical Research Coordinator (CRC) and trains you to become a certified CRC at UCI. The program is designed to give you a deep understanding of cell and gene therapy research and clinical trials.

Goals of the program include:

  • Teach CRC responsibilities and practical skills for daily tasks.
  • Train CRCs in cell and gene therapy clinical trials.
  • Expand knowledge of CRCs in best practices for documentation, informed consent, data management, security, monitoring and reporting adverse events, working with regulatory boards and starting and managing studies.

To apply, you need to have completed basic biology or chemistry courses, or the SCRC stem cell techniques course. You can email your resume and cover letter to Yuna Muyshondt or call 949-824-9621 or 714-456-2275. Please contact Yuna if you have any questions.

Alpha Clinic Clinical Trials Investigator Training Program

The Alpha Clinic Clinical Trials Investigator Training Program (ACCTITP) aims to promote equitable delivery of advanced therapeutics through educating community physicians, advanced practice providers (APPs), and pharmacists on scientific progress in regenerative medicine and training them in cell and gene therapy clinical methodology.

  • The ACCTITP will be offered as a certificate through UCI SOM Office of Medical Education (certificate approval in process).
  • The lectures will be offered as weekly two-hour lecture sessions for 20 weeks (Thursdays from 6:00-8:00 pm over Zoom) with ten half-day clinical research observational sessions in the UCI AC clinics and inpatient units.

Resources outside of UCI Alpha Clinic

A Closer Look at Stem Cells

Learn more about stem cell research and its potential to impact human health

Looking for a clinical trial that's right for you?

Find a Trial

Contact the UCI Alpha Clinic Team

Thank you for your interest with our team.

A member of our staff will be in contact with you soon.

Privacy Policy

University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

  • Please read the information below and ask questions about anything that you do not understand. A
    researcher listed above will be available to answer your questions.
  • You are being asked to participate in a clinical research potential participant database to identify
    potential clinical research studies you may be eligible for. Participation in this database is voluntary.
    You may choose to skip any question. You may refuse to participate or discontinue your involvement
    at any time without penalty or loss of benefits. You are free to withdraw from this database at any
    time. If you decide to withdraw from this database you should notify the research team
    immediately    .
  • You are eligible to participate in this study if you may be interested in participating in a research trial at UCI Health
  • We would like to interview you to learn more about your eligibility for current clinical research studies at UCI. The interview will last about 5-30 minutes, depending on the extent of your medical history.
  • Possible risks/discomforts associated with the database are hearing about potential clinical research studies that may not be of interest to you, invasion of your privacy, or a potential breach of confidentiality.
  • There are no direct benefits from participation in the database. However, this database may help inform you on clinical research studies that you may be eligible for. Participation in UCI clinical research studies help us gain important data and knowledge that may lead to improved treatment options for people with similar conditions to you in the future.
  • There are no alternative procedures available. The only alternative is not to participate in this study.
  • There is no compensation for your participation in this database.
  • There is no cost to you for participation in this database.
  • All information collected will be stored confidentially in a world-class securely-hosted application, “RealTime CTMS,” with robust data protections and encryption. This application has HIPAA compliant architecture and application rules to ensure data privacy and regulatory compliance.
  • Researchers will use your information to assess your eligibility for current and future clinical research studies at UCI. You may opt out at any time.
  • The research team, authorized UCI personnel, and regulatory entities, may have access to your study records to protect your safety and welfare.
  • While the research team will make every effort to keep your personal information confidential, it is possible that an unauthorized person might see it. We cannot guarantee total privacy.
  • Future Research Use
    Researchers will use your information to conduct this study. Once the study is done using your information, we may share them with other researchers so they can use them for other studies in the future. We will not share your name or any other private identifiable information that would let the researchers know who you are. We will not ask you for additional permission to share this de-identified information
  • Data Retention - In accordance with UC Office of the President policy, information will be retained for 10 years after the end of the calendar year in which the research is completed.
  • If, during the course of this study, significant new information becomes available that may relate to your willingness to continue to participate, this information will be provided to you by the research team listed at the top of the form.
  • If you have any comments, concerns, or questions regarding the conduct of this research please contact the researchers listed at the top of this form
  • Please contact the UCI Institutional Review Board by phone, (949) 824-8170, by e-mail at IRB@research.uci.edu or at 160 Aldrich Hall, Irvine, CA 92697-7600 if you are unable to reach the researchers listed at the top of the form and have general questions; have concerns or complaints about the research; have questions about your rights as a research subject; or have general comments or suggestions.
What is an IRB? An Institutional Review Board (IRB) is a committee made up of scientists and nonscientists. The IRB’s role is to protect the rights and welfare of human subjects involved in research. The IRB also assures that the research complies with applicable regulations, laws, and institutional policies. UCI