Cellebration Life Sciences, Inc. Diabetes Clinical Trials
Cellebration Life Sciences, Inc., a leader in regenerative technologies, is in the process of obtaining approval from the United States Food and Drug Administration (FDA) to conduct Type 2 Diabetes Clinical Trials focused on the development of a stem cell-based treatment.
Led by Cellebration’s Chairman and Co-Founder Dr. Anand Srivastava, our team of scientists is further investigating a new potential approach to combat this disease, achieved through the differentiation of stem cells into insulin-secreting cells. Under Dr. Srivastava’s leadership, the San Diego-based company carries on a tradition of groundbreaking research in the field of stem cell science spanning more than two decades.
“The conventional approach to this epidemic,” noted Dr. Srivastava, “has primarily involved pharmaceutical products, which have several limitations. Cellebration’s research into stem cells may provide an alternative that addresses these concerns. In contrast to the adverse side effects seen with drug therapies; the post-procedure symptoms of stem cell therapy are limited mainly to mild fever, nausea, and headache.
Furthermore, rather than simply “masking” the symptoms of diabetes, stem cells have the potential to provide a lasting cure. More than 150 clinical trials listed on the National Institutes of Health (NIH) website have revealed several potential benefits of stem cell implantation or infusion for the treatment of diabetes. Clinical parameters such as Hemoglobin A1c (HbA1c) decreased considerably after stem cell administration, as did the required amounts of insulin needed to manage blood glucose.
In addition, patients who received the treatments showed improved responsiveness to insulin. In most cases, patients continued to enjoy these benefits several months after following up.
Dr. Srivastava’s studies focus on the therapeutic benefits of mesenchymal stem cells (MSCs). Isolated from visceral fatty tissues of adults, MSCs are known to improve pancreatic function, prevent cell death, decrease systemic oxidative stress, and reduce insulin resistance through the secretion of paracrine factors.
Additionally, after exposure to interferon gamma (IFN-γ) and other pro-inflammatory cytokines, MSCs may become a source of anti-inflammatory cytokines which may generate new insulin-producing cells.
Finally, intravenous infusion of stem cells has been shown to regenerate beta cells of pancreatic islets and promote insulin sensitivity by decreasing systemic inflammation – the root cause of insulin resistance. “Stem cell therapy may offer a long-lasting therapeutic alternative for treating Type 2 diabetes,” Dr. Srivastava said. “However, additional research is needed, as this is not yet a permanent cure. We intend to achieve complete efficacy through the clinical trial approval process,” he concluded.
The Therapeutic Benefit of Mesenchymal Stem Cells (MSCs) Isolated from Visceral Fatty Tissues of Adults for Diabetes Type 2
Step 1 - Discovery and Development
Discovery
Typically, researchers discover new therapies through:
- New insights into Diabetes Type 2 that allows researchers to isolate Stem Cells and infuse into the body to stop or reverse the effects of the disease.
- Many tests to find beneficial effects of Stem Cells for the treatment of Diabetes Type 2.
- New technologies, such as those that provide new ways to target Stem Cells to specific sites within the body to illicit responsiveness to insulin.
At this stage in the process, Stem Cell therapy may be a potential candidate for development as a medical treatment for Diabetes Type 2 that calls for further study.
Development
Once researchers identified and isolated mesenchymal stem cells (MSCs) from the visceral fatty tissues to infuse into the body, experiments are conducted to gather information on:
- How the Stem Cells are absorbed, distributed, and metabolized.
- The Stem Cells potential benefits and mechanisms of action.
- The optimal infusion amounts.
- The optimal mode of infusion.
- Side effects or adverse events that can often be referred to as toxicity.
- How Stem Cell therapy affects different groups of people (such as by gender, race, or ethnicity).
- How Stem Cells interacts with other drugs and treatments.
Step 2 - Preclinical Research
Before testing Stem Cell therapy in people, researchers determine if there is a potential to cause serious harm, also called toxicity. The two types of preclinical research are:
- In Vitro
- In Vivo
FDA requires researchers to use good laboratory practices (GLP), defined in medical product development regulations, for preclinical laboratory studies. The GLP regulations are found in 21 CFR Part 58.1: Good Laboratory Practice for Nonclinical Laboratory Studies. These regulations set the minimum basic requirements for:
- study conduct
- personnel
- facilities
- equipment
- written protocols
- operating procedures
- study reports
- and a system of quality assurance oversight for each study to help assure the safety of FDA-regulated product
Usually, preclinical studies are not very large. However, these studies must provide detailed information on dosing and toxicity levels. After preclinical testing, researchers review their findings and decide whether Stem Cells therapy should be tested in people.
Step 3 - Clinical Research
While preclinical research answers basic questions about Stem Cell therapy’s safety, it is necessary to study ways the Stem Cells infused will interact with the human body. “Clinical research” refers to studies, or trials, that are done in people. As the developers design the clinical study, they will consider what they want to accomplish for each of the different Clinical Research Phases and begin the Investigational New Drug Process (IND), a process they must go through before clinical research begins. The Following is information on Designing Clinical Trials, Clinical Research Phase Studies, The Investigational New Drug Process, Asking for FDA Assistance, FDA IND Review Team and Approval.
Designing Clinical Trials
Researchers design clinical trials to answer specific research questions related to Stem Cell therapies. These trials follow a specific study plan, called a protocol, that is developed by the researcher. Before a clinical trial begins, researchers review prior information about the drug to develop research questions and objectives. Researchers consider the following:
- Who qualifies to participate (selection criteria)
- How many people will be part of the study
- How long the study will last
- Whether there will be a control group and other ways to limit research bias
- How the Stem Cells will be given to patients and the amount of cells
- What assessments will be conducted, when, and what data will be collected
- How the data will be reviewed and analyzed
Clinical trials follow a series from early, small-scale, Phase 1 studies to large late-stage, Phase 3 studies.
Clinical trials follow a series from early, small-scale, Phase 1 studies to large late-stage, Phase 3 studies.
Phase 1
Study Participants: 20 to 100 people with Diabetes Type 2.
Length of Study: Several months
Purpose: Safety and dosage
Approximately
Phase 2
Study Participants: Up to several hundred people with Diabetes Type 2
Length of Study: Several months or up to 2 years
Purpose: Efficacy and side effects
Approximately
Phase 3
Study Participants: 300 to 3,000 people with Diabetes Type 2
Length of Study: 1 to 4 years
Purpose: Efficacy and monitoring of any adverse reactions
Approximately
Phase 4
Study Participants: Several thousand people with Diabetes Type 2
Purpose: Safety and efficacy
The Investigational Stem Cell Therapy Process
Researchers must submit an Investigational New Drug (IND) application to FDA before beginning clinical research. In the IND application, researchers must include:
- Any animal study data and toxicity (side effects that cause great harm) data
- Clinical protocols (study plans) for studies to be conducted
- Data from any prior human research
- Information about the researcher
Researchers are free to ask for help from FDA in the Stem Cell development process, including:
- Pre-IND application, to review FDA guidance documents
- After Phase 2, to obtain guidance on the design of large Phase 3 studies
- Any time during the process, to obtain an assessment of the IND application
FDA IND Review Team
The review team consists of a group of specialists in different scientific fields. Each member has different responsibilities.
- Project Manager: Coordinates the team’s activities throughout the review process and is the primary contact for the sponsor.
- Medical Officer: Reviews all clinical study information and data before, during, and after trial
- Statistician: Interprets clinical trial designs and data and works closely with the medical officer to evaluate protocols and safety and efficacy data.
- Pharmacologist: Reviews preclinical studies.
- Pharmakineticist: Focuses on the Stem Cells absorption, distribution, metabolism, and excretion processes. Interprets blood-level data at different time intervals from clinical trials, as a way to assess dosages and administration schedules.
- Chemist: Evaluates Stem Cells composition. Analyzes how the Stem Cell was obtained, the stability, quality, continuity, the presence of impurities.
- Microbiologist: Reviews the data submitted.
Approval
The FDA review team has 30 days to review the original IND submission. The process protects volunteers who participate in clinical trials from unreasonable and significant risk in clinical trials. FDA responds to IND applications in one of two ways:
- Approval to begin clinical trials.
- Clinical hold to delay or stop the investigation. FDA can place a clinical hold for specific reasons, including:
- Participants are exposed to unreasonable or significant risk.
- Investigators are not qualified.
- Materials for the volunteer participants are misleading.
- The IND application does not include enough information about the trial’s risks.
A clinical hold is rare; instead, FDA often provides comments intended to improve the quality of a clinical trial. In most cases, if FDA is satisfied that the trial meets Federal standards, the applicant can proceed with the proposed study. The researcher is responsible for informing the review team about new protocols, as well as serious side effects seen during the trial. This information ensures that the team can monitor the trials carefully for signs of any problems. After the trial ends, researchers must submit study reports. This process continues until the researcher decides to end clinical trials or files a marketing application. Before filing a marketing application, a researcher must have adequate data from two large, controlled clinical trials.
Step 4 - FDA Stem Cell Therapy Review
If Stem Cell therapy has evidence from its early tests and preclinical and clinical research that treatment is safe and effective for Diabetes Type 2, the researcher can file an application to market the therapy. The FDA review team thoroughly examines all submitted data on Stem Cell therapy and decides to approve or not to approve it.
New Drug Application
A New Drug Application (NDA) tells the full story of Stem Cell therapy for Diabetes Type 2. Its purpose is to demonstrate that Stem Cell therapy is safe and effective for its intended use in the population studied. The researcher includes everything about the therapy -from preclinical data to Phase 3 trial data- in an NDA. Researchers must include reports on all studies, data, and analyses. Along with clinical results, researchers must include proposed labeling, safety updates, patent information, any data from studies conducted outside the United States, institutional review board compliance information.
FDA Review
Once the FDA receives an NDA, the review team decides if it is complete. If it is complete, the review team has 6 to 10 months to decide on whether to approve the Stem Cell therapy for the treatment of Diabetes Type 2. The process includes the following:
- Each member of the review team conducts a full review of the application. Within each technical discipline represented on the team, there is also a supervisory review.
- FDA inspectors travel to clinical study sites to conduct a routine inspection. The project manager assembles all individual reviews into an “action package.” This document becomes the record for FDA review. The review team issues a recommendation, and a senior FDA official decides.
FDA Approval
In cases where FDA determines that Stem Cell therapy for Diabetes Type 2 has been shown to be safe and effective, it is then necessary to work with the researcher to decide whether to continue further development. FDA may organize a meeting of one of its Advisory Committees to get independent, expert advice and to permit the public to make comments. These Advisory Committees include a Patient Representative that provides input from the patient perspective.
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