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| Name | Class |
|---|---|
| Clinius Ltd | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liponovo tissue product and Ringer Acetat injections | Experimental | Investigational products (Liponovo tissue product and Ringer Acetat) are injected into the dorsal forearm, superficial part of the subcutis. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liponovo tissue product | Other | Investigational products (Liponovo tissue product and Ringer Acetat) are injected into the dorsal forearm, superficial part of the subcutis. The single injection and a 23G/30mm needle are used. The amount of the injected investiogational products is 4,5 ml for both dorsal forearms (together 4,5ml x2 = 9ml / test subject). The product is always injected in the proximal third of the forearm, into a standardized a quarter circle with a radius of 30mm. Both injections are performed with covered syringe to ensure the double-blinding. After the injection, test subjects get a cold on the injection sites to reduce the bruising. |
| Measure | Description | Time Frame |
|---|---|---|
| Acute local reactions 20 minutes after injection | Examination and structured interview 20 minutes after injection by the investigator | Day 0 |
| Acute and mid-term adverse events, incl severe adverse events | E-dairy filled out by the participants | Day 0-7, Day 30, and Day 60 |
| Acute and mid-term adverse events, incl severe adverse events | Evaluation and structured interviews by the investigator | Day 90 |
| Acute and mid-term adverse events, incl severe adverse events | Structured telephone interview by study nurse | Day 7 and Day 9 |
| Delayed allergic reactions | Participant's e-dairy | Day 0-7, Day 30, and Day 60 |
| Delayed allergic reactions | Telephone interviews by the study nurse | Day 2, and Day 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Terveystalo, Ruoholahti | Helsinki | Finland |
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Participants are not randomized into different arms. Instead, the side (left or right forearm) receiving the investigational product vs. placebo is randomized for each participant.
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Participants and investigators are blinded to which arm receives placebo vs. investigational product
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