An Investigator Initiated Study (IIS) is unsolicited, independent clinical or scientific research where a researcher, academic institution, or private institution serves as the Sponsor and Cytori provides support. Such studies are initiated and managed independently of Cytori.
The objective of Cytori’s IIS Program is to support clinical and scientific research intended to advance knowledge and understanding of its products in the treatment of medical diseases and conditions that may benefit from cell therapy or nanomedicine.
The program is open to all researchers or institutions who are interested in conducting studies with Cytori products. Cytori is not the sponsor of these studies. While these studies are independent from Cytori-sponsored clinical studies, they should be consistent with the direction of Cytori’s clinical development program.
The program has been designed to support researchers and institutions who are not affiliated with Cytori and whose efforts are aimed at addressing relevant clinical and scientific questions in areas of interest to Cytori.
IIS proposals may include:
- Prospective clinical studies of approved and unapproved uses related to Cytori products
- Retrospective clinical studies of approved and unapproved uses related to Cytori products
- Animal studies involving Cytori products
- Bench studies
Requests should be focused and specific. In general, Cytori will only provide scientific support (i.e. medical information, treatment regimens used for other research or clinical applications). Support for research beyond scientific support is limited.
Cytori will acknowledge receipt of all IIS submissions. The review process is conducted by the Cytori Scientific Review Committee and decisions are based upon medical and scientific merit as well as the available resources and research priorities. Cytori will make every attempt for a speedy review process and to communicate the process timelines to the Investigator during the course of the review process. A formal notification on the status of an application will be sent once a decision is reached. While all requests will be reviewed, Cytori makes no guarantee that it will approve all requests. Support of a study in no way implies any obligation toward or is any way connected to the recommendation or prescribing of Cytori products.
A submission must contain enough detail about the research study and the IIS request to enable Cytori to make a final evaluation regarding support. When submitting a proposal, the following information will be requested:
- Clinical site information including Principal Investigator (please include medical license number) and information for the contact person
- Project description including hypothesis and objectives, study title, phase of research (i.e. pre-clinical, clinical within current indication, clinical in unapproved indication), population, treatment regimen, enrollment and approximate study dates
- Study outline of draft protocol
- Draft informed consent if study proposal involves humans
- Nature of request to Cytori (product, treatment regimens, data management, etc.)
- Curriculum Vitae of any sub-investigators and other clinical staff expected to participate in the study
- Statement that no one to be involved in the investigation had been disqualified, debarred or otherwise under investigation by a Regulatory or Institutional body.
Upon approval of the Full Proposal, the following documents are required:
- Final Study Protocol and Informed Consent Form
- IRB/ethics committee approval letter of final Study Protocol and Informed Consent
- Submission/approval of regulatory documents (IDE, CTA, or other regulatory approvals) if required and commitment to comply with regulatory requirements as per local regulations
- Signed IIS Agreement
Cytori requires at least one study status update per quarter unless otherwise specified. Updates should include information on enrollment, serious adverse events (SAEs), projected publications and study completion dates. Additional requirement for the provision of safety information is included in the following section. Cytori also requires notification of any amendments to the original protocol after the study has been initiated. An Investigator conducting an IIS is required to provide Cytori with a written report of the final study results. Any planned publications or presentation must be sent to Cytori in advance of a submission.
Cytori has the ethical and legal responsibilities to collect and analyze safety information on its investigational and marketed products so that the company can fully understand their risk-benefit profile and provide accurate safety information to regulatory authorities, physicians and patients. Independent investigators conducting research involving Cytori products have the key role in monitoring the study and reporting all significant (i.e. serious) safety events to Cytori.
As the sponsor of an IIS, the Investigator and/or Institution must ensure that the study is conducted in accordance with the provision of all applicable laws, rules and regulations, including the International Committee for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines and all applicable local and regulatory requirements. The Investigator must assume all regulatory responsibilities including, but not limited to, Institutional Review Board (IRB) / Ethics Committee (EC) approvals, informed consent, regulatory approvals, and any and all reporting obligations to local regulatory authorities.
Cytori encourages Investigators to publish the results of the study, whether or not the results are favorable to the Cytori product. The Investigator will comply with recognized ethical standards concerning publications and authorship such as those established by the International Committee of Medical Journal Editors. Cytori reserves the right to first review of any draft publications.
Where applicable, as a publicly traded company, Cytori is dedicated to transparency relating to its financial relationships with Investigators and study sites; therefore Cytori may publicly disclose funding associated with an IIS.