Study Participation

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In the US, InGeneron’s Transpose® Ultra System is for investigational use only. Although patients who are accepted to participate in a clinical trial have the option to withdraw or might be excluded for certain reasons, the success of clinical trials is enhanced when the participating patients complete the full trial, including all follow-up. Generally, the patient commitment will involve regular clinic visits over an approximately 12-month period. Patient dropouts could result in inadequate data to determine the success of a clinical trial.

Ongoing Clinical Trials

InGeneron is presently conducting clinical studies using patients’ own regenerative cells to treat several different orthopedic conditions. These include:

  • Rotator cuff tears, which are tears in a person’s tendon that contribute to shoulder pain, dysfunction and occupational disability. InGeneron’s rotator cuff study is currently in the pivotal trial phase.
  • Facet joint syndrome, which is associated with the inflammation of a person’s facet joint, located in the spine, leading to degeneration and cartilage loss. InGeneron’s facet joint study is currently in the feasibility trial phase.
  • Wrist osteoarthritis, which can result in bone spurs and bone cysts in the wrist, as well as a degeneration of cartilage. These conditions can cause inflammation and pain and can lead to a reduction in grip strength and limited range of motion. InGeneron’s wrist osteoarthritis study is currently in the feasibility trial phase.

We believe – and are working to demonstrate – that these therapies open a new category of treatment for pain and functionality that improves upon those that currently exist.

Participating in a Clinical Trial

All clinical trial designs differ and are customized to the specific indication. But generally, this is what you can expect if you participate in one of our clinical trials:

  • You will be screened by a physician at a participating site to determine if you fulfill the inclusion criteria for the trial.
  • If you fulfill the criteria and continue to be interested in participating, the complete clinical trial process and its interventions will be explained to you in detail. Following that, you will be presented with a consent form and asked if you fully understand its content. You will then be asked to sign the form.
  • There will be no compensation for your participation in the trial.
  • Our clinical trials are randomized. That means you will be randomly assigned to one of two groups: the group that will receive a cell therapy using the InGeneron platform, or the group that receives treatment using the current standard of care as described in the study protocol. Neither you nor the clinical team that follows you through the clinical trial will be informed as to which of these two groups you have been assigned. The chance of being assigned to the cell-therapy group, however, is at least 50 percent.
  • Following the initial treatment—either the cell therapy or the currently available therapy—you will be monitored over an extended period of time. You will be asked to report on your health status and will need to see the treating physician for ongoing follow-up visits. The final visit typically occurs 12 months after the initial treatment, at which time you will be assessed in comparison to the assessment of the initial visit. The data that is gathered from this comparison will be analyzed to determine the benefit of the cell therapy relative to the current standard.
  • When the trial is completed and its results are published, you can inquire as to which of the two groups described above you were randomly assigned.

You may find a study site that is close to you on our overview of Clinical Study Sites. You will also be able to contact the physicians directly from this site.

Please contact us at [email protected] if you are interested in learning even more about our clinical trials. Please be aware that only a small number of patients can participate in these trials and typically patients need to live close to a participating site.