Regenerative Medicine / Gene Therapy
More than 50% of CTI's active prospective studies involve regenerative medicine,
and we contributed to the development programs of several of the world's first approved gene therapy products
We understand the specific challenges these projects present, including regulatory hurdles, complex logistics around biological sample collection, shipment, and implantation, as well as complicated site training requirements based on unique cell and gene technologies. Our experience includes both autologous and allogeneic stem cells as well as other cell/gene interventions. We work with innovators, key opinion leaders, cutting edge biotechnology/pharmaceutical companies, and investigators on our ongoing programs, as well as participate in industry groups such as the Alliance for Regenerative Medicine (ARM). We are committed to the advancement of important, life-changing therapies, and we support innovation by sponsoring and speaking at industry meetings such as Cell & Gene Meeting on the Mesa, RegenMed Investor Day, and the Advanced Therapies Summit.
We offer our sponsors:
- An employee turnover rate less than half of the reported industry average, resulting in team continuity over long follow-up trials
- International experience in trial execution with cell and gene therapies
- Personnel with knowledge of the unique challenges of cell/gene therapy trials
- Medical personnel with cell/gene laboratory management experience
- Experience with first-in-human, first-in-class, and first-in-patient trials
- Personal relationships with key investigators and site personnel
- Executive management involvement on every project
- CTI studies regularly exceed industry standards for enrollment, despite challenging patient populations
- A proven track record of success with more than 100 drug and device approvals
Some of our adult and pediatric experience includes:
- Acute lymphoblastic leukemia
- Acute lymphoblastic lymphoma
- Adenocarcinoma
- Adenovirus
- Advanced liver cancer
- Allogeneic hematopoetic stem cell transplantation
- B cell lymphoma
- Beta hemoglobinopathies
- BK virus
- Beta-Thalassemia
- Bronchopulmonary dysplasia
- Childhood cerebral adrenoleukodystrophy
- Choroideremia
- Chronic kidney disease
- Crohn's disease
- Cytomegalovirus
- Degenerative disc disease
- End-stage renal disease
- Farber disease
- Hematologic malignancy (AML, ALL, or MDS)
- Hematopoietic stem cells
- Kidney cell
- Kidney transplant
- Metabolic diseases
- MPS I
- MPS II
- Non-hodgkin's lymphoma
- Osteoarthritis
- Peritoneal mesothelioma
- Retinal dystrophy
- Severe sickle cell disease
- TK2 deficiency
- Type I Diabetes Mellitus
- Type II Diabetes