US Stem Cell Inc (USRM)

[Gsdubb]

I emailed clinicaltrials.gov and this was the response I got:

There are two main reasons to register:

1. Required by law. Section 801 of the Food and Drug Administration (FDA) Amendments Act:

U.S. Public Law 110-85 (Food and Drug Administration Amendments Act of 2007 or FDAAA), Title VIII, Section 801 mandates that a "responsible party" (i.e., the sponsor or designated principal investigator) register and report results of certain "applicable clinical trials":
Trials of Drugs and Biologics: Controlled, clinical investigations, other than Phase I investigations, of a product subject to FDA regulation;

Trials of Devices: Controlled trials with health outcomes of a product subject to FDA regulation (other than small feasibility studies) and pediatric postmarket surveillance studies.

"Applicable clinical trials" generally include interventional studies (with one or more arms) of drugs, biological products, or devices that are subject to FDA regulation, meaning that the trial has one or more sites in the U.S, involves a drug, biologic, or device that is manufactured in the US (or its territories), or is conducted under an investigational new drug application (IND). For the complete statutory definitions and more detailed information on the agency's current thinking about their meaning, see this pdf document.


http://prsinfo.clinicaltrials.gov/ElaborationsOnDefinitions.pdf

The law requires you to register before 21 days after enrollment.


2. The International Committee of Medical Journal Editors (ICMJE)

Please refer to the International Committee of Medical Journal Editors (ICMJE) statement: "Obligation to Register Clinical Trials." available at: http://www.icmje.org/publishing_10register.html.

Please also read their FAQ located at http://www.icmje.org/faq_clinical.html.

Note in particular, "We urge all parties to register new and ongoing clinical trials. If in doubt about whether a trial is "clinically directive," register it."

Also, ClinicalTrials.gov encourages registration of all clinical trials with the goal of establishing a comprehensive registry, not only for
patients currently looking to participate in ongoing trials, but for patients, researchers, and editors who want to know what interventions
have been studied in the past (e.g., for systematic reviews).

Please be aware that ClinicalTrials.gov is an independent entity from the ICMJE -- we neither represent the ICMJE nor their statements/policies. ClinicalTrials.gov *does* provide a mechanism that allows sponsors to register trials in compliance with the ICMJE criteria. [For detailed questions about the ICMJE policy, please contact them directly -- contact
information is available at the ICMJE Web site at http://www.icmje.org/]

The ICMJE policy requires you to register prior to enrollment.

Thank you,
PRS TEAM
ClinicalTrials.gov

If you did not get an adequate answer to your question or your problem has not been resolved, please email us back at [e-mail].

Investigator's Login Page: http://register.clinicaltrials.gov
Study Record Managers’ Information: http://www.clinicaltrials.gov/ct2/help/for-manager
Protocol Detailed Review Items: http://prsinfo.clinicaltrials.gov/ProtocolDetailedReviewItems.pdf

Since Mirror is oUS to save money, it is not registered with the FDA which is what I was saying in several earlier posts weeks and months ago.
They still have to follow strict protocols and guidelines in order to satisfy the BLA panel for approval.