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Expanded Access Policy to Investigational  Products

Updated: March 9, 2020

Castle Creek Biosciences, Inc. (Castle Creek) is developing innovative therapies for patients with rare and serious diseases affecting the skin and connective tissue. The company’s clinical development resources are focused on conducting clinical studies required by the US FDA and other regulatory authorities to establish the potential risks and benefits of our investigational products, and to obtain regulatory approval. As a result, participation in clinical trials should be the primary route by which patients access investigational products.

CCB is committed to making investigational products available to seriously ill patients who have exhausted other treatment options under appropriate conditions. The purpose of this policy is to describe the requirements for Expanded Access to CCB investigational products to patients outside of a clinical study.


Scope

This policy applies to provision of access to a CCB investigational product that is not approved for any purpose in the country from which the requested investigational product is intended to be used.

Policy Statements

Any use of a CCB investigational product outside of a clinical study must be in accordance with local laws and regulations governing such programs, including CCB policies and procedures.

In general, where permitted by local regulation, the CCB investigational product supplied via Expanded Access will no longer be provided by CCB when it becomes available via the local healthcare system.

CCB does not intend to provide an investigational product under this policy if the Company does not intend to market the product in the country.


Patient Eligibility Criteria

To be eligible for access to a CCB investigational product, patients must meet the following criteria:

  • Suffer from a serious or immediately life-threatening disease or condition.
  • Have undergone appropriate standard treatments without success and no comparable or satisfactory alternative treatment is available or exists to treat the disease or condition.
  • Have attempted to access other investigational products with more completely understood or better benefit-risk profiles.
  • Are ineligible for participation in any ongoing clinical study of the investigational product.
  • The patient has a disease for which there is sufficient evidence of a projected benefit from the use of the investigational product and the benefit outweighs the known or anticipated risks.
  • There is adequate information to support appropriate dosing for a special population patient such as pediatric, elderly, renal or hepatic disease, etc.
  • Any other pertinent medical criteria for access to the investigational product, as established by the clinical development leadership at CCB.


Investigational Product Criteria

In addition to the patient eligibility requirements, the CCB investigational product must meet the following criteria:

  • The product is under investigation in a CCB development program in one or more clinical studies for the same disease that the investigational product is being requested for.
  • There are adequate data from clinical studies supporting the use of the investigational product for the patient requesting compassionate use.
  • The provision of the investigational product will not interfere with or compromise the clinical development of the product.
  • There are adequate supplies of the investigational product.
  • CCB has the financial ability to provide the investigational product for expanded access equitably to all potential eligible patients.


Treating Physician Criteria and Responsibilities

The physician(s) attending to the patient(s) who is/are receiving a CCB investigational product through compassionate use access is (are) properly licensed and fully qualified to receive and administer the product. The physician must agree in writing to:

  • Comply with any applicable country-specific legal and regulatory requirements related to providing an investigational product under Expanded Access.
  • Review the Investigator’s Brochure for the investigational product.
  • Comply with any CCB requirements in terms of medical criteria, safety reporting, drug supply/use and protection of intellectual property.
  • A treating physician may submit questions or requests regarding expanded access to please insert CCB contact email


Timeline

CCB will consider requests for expanded access on a case-by-case basis.  Because the circumstances of each request are different, there is no guarantee that expanded access will be granted for any of our investigational products.  CCB anticipates acknowledging receipt of requests for expanded access within 5 business days.

Do you have any questions?

You will find information about CCB’s investigational products  at fibrocell.com under the tab, “Pipeline & Clinical Trials.” If you have questions, please send an email to ea@castlecreekbio.com.

Please note: This policy is subject to change at the discretion of CCB and subsequently, this web page will be updated to reflect any revisions to the policy.