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Cell Therapy Forum

Support for Clinical Trials with Cell Therapies

The Johns Hopkins Cell Therapy Forum oversees requests for research services provided by the Johns Hopkins Hemapheresis and Transfusions Support (HATS) Center: Apheresis Program, Cell Therapy Lab, the Sidney Kimmel Comprehensive Cancer Center Inpatient/Outpatient Program Services (IPOP), the Institute for Clinical and Translational Research (ICTR) Clinical Research Unit (CRU), regulatory guidance, budgetary review, or other support.

Cell therapy products must be collected and processed in facilities that meet FACT accreditation standards and meet requirements specified by the Maryland Department of Health, including, in many cases, issuance of a State of Maryland Tissue permit.

The Johns Hopkins Apheresis Program offer a wide range of services in line with the guidelines set forth by the American Society for Apheresis (ASFA). These include:

  • Plasmapheresis/therapeutic plasma exchange
  • Erythrocytapheresis (red cell exchange)
  • Lipid apheresis
  • Therapeutic leukapheresis
  • Stem Cell collections
  • Clinical / Commercial CAR T-cell collections
  • Platelet Depletion
  • WBC Depletion

The Johns Hopkins Cell Therapy Lab adheres to these requirements, and provides the following:

  • Biologic product development and testing
  • Consultative support for biologic development
  • Good Manufacturing Practices (GMP) expertise to produce and maintain cell therapy products

Clinical Research Support Services Requests

Requests to utilize these clinical research support services may be submitted. Once submitted and reviewed, requests for support are presented at the cell therapy forum. Following this discussion, requests are prioritized for clinical trial in the context of other studies actively recruiting and planned at Johns Hopkins Medicine

Submit a Request
PI/Study Team receives Start-Up Packet Communication with Study Teams  Study Presentation Preparation   Cell Therapy Forum Steering Committee Discussion
  • Submit to RedCap
Fill out the Cell Therapy Request Intake form to begin the review process.
  • Review of protocol
  • Dialogue with study team about needed trial support
  • Distribution of study documents to requested services (i.e. CTL, HATS, etc.)
  • Scheduling Cell Therapy Forum Presentation
  • The OCT will send template presentation slides for the study team to complete prior to the Cell Therapy Forum presentation
  • We will also give you the date of the Cell Therapy Forum (3-6 weeks to prepare)
  • Presentation for group discussion and feedback
  • Following presentation, OTC will communicate regarding outstanding questions
  • Cell Therapy Forum Steering Committee will discuss feasiblity and prioritization of study
  • Study team will receive formal communication regarding next steps. including anticipated timeline to activation if approved

Monthly CTF Meetings

The Cell Therapy Forum meets monthly, and the submission deadline for protocols is 2 weeks prior to the scheduled meeting date.

The 2024/2025 schedule for the Cell Therapy Forum

  • December 11th, 2024 at 12pm
  • January 29th, 2025 at 12pm
  • February 26th, 2025 at 12pm
  • March 26th, 2025 at 12pm
  • April 30th, 2025 at 12pm
  • May 28th, 2025 at 12 pm
  • June 25th, 2025 at 12pm
  • July 30th, 2025 at 12pm
  • August 27th, 2025 at 12pm
  • September 24th, 2025 at 12pm
  • October 29th, 2025 at 12pm

Resources

Contact Us

Contact us with any questions regarding the Cell Therapy Forum and its approval process.

Email Us