Evaluating the Safety and Tolerability of the Liponovo Tissue Product in Healthy Volunteers
Overview
- Phase
- Not Applicable
- Intervention
- Liponovo tissue product
- Conditions
- Safety Issues
- Sponsor
- Linio Biotech Oy
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Acute local reactions 20 minutes after injection
- Status
- Completed
- Last Updated
- 3 months ago
Overview
Brief Summary
The study is a randomized, double blinded, bilaterally controlled trial.The aim is to evaluate the short- and mid term safety of cell-free adipose tissue product. The safety of the tissue product is to be studied in 40 healthy volunteers. Cell-free tissue product is injected into superficial part of the subcutis with one injection to standardized area. The volume of the injection is 4,5 ml. As the control method, the same size area is injected with plain Ringer-Acetat solution. The adverse events and serious adverse events are monitored in doctor visits, phone calls and e-diary.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult (age 18 years or more)
- •Healthy skin in the studied area (dorsal forearm, proximal third)
- •Able and willing to give informed consent
- •Reasonably accessible to the study clinic and compliant to follow-up visits
Exclusion Criteria
- •known allergy to any of the preparations used in the study (Liponovo tissue product and Ringer-Acetat) or earlier/known anaphylaxis reaction for any allergen
- •hematologic or other bleeding disorder
- •use of antitrombotic/ anticoagulation medicine
- •autoimmune disease
- •immunosupressive disease or medication
- •cancer or neoplastic disease
- •connective tissue disease
- •diabetes type 1 or 2 or other metabolic diseases
- •pregnancy or nursing
- •sunbathing during last 7 days
Arms & Interventions
Liponovo tissue product and Ringer Acetat injections
Investigational products (Liponovo tissue product and Ringer Acetat) are injected into the dorsal forearm, superficial part of the subcutis.
Intervention: Liponovo tissue product
Outcomes
Primary Outcomes
Acute local reactions 20 minutes after injection
Time Frame: Day 0
Examination and structured interview 20 minutes after injection by the investigator
Acute and mid-term adverse events, incl severe adverse events
Time Frame: Day 7 and Day 9
Structured telephone interview by study nurse
Delayed allergic reactions
Time Frame: Day 2, and Day 7
Telephone interviews by the study nurse
Acute and mid-term adverse events, incl severe adverse events
Time Frame: Day 0-7, Day 30, and Day 60
E-dairy filled out by the participants
Acute and mid-term adverse events, incl severe adverse events
Time Frame: Day 90
Evaluation and structured interviews by the investigator
Delayed allergic reactions
Time Frame: Day 0-7, Day 30, and Day 60
Participant's e-dairy