Assessment of the Trophic and Anti-inflammatory Effect of SVF Added With HPLNCT04225481
Evaluation of Enhanced Therapeutic Effect of Adipose Stromal Vascular Fraction Added With Human Platelet Lysate in Treatment of Osteoarthritis
An observational study of Assessment of the Trophic and Anti-inflammatory Effect of SVF Added With HPL, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio.
Trial summary
Osteoarthritis (OA) is a highly progressive and debilitating joint disease. Recently, it was demonstrated the existence of an important link between OA inflammation and progression of structural changes. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Assessment of the Trophic and Anti-inflammatory Effect of SVF Added With HPL
- What is being tested?
- isolation of waste material and culturing with different supplement culture media
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- Jan 2020to Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy subjects undergoing aesthetic plastic surgery or OA patients undergoing prosthetic surgery
Who may be able to join
- OA patients
- Subscription of informed consent
- BMI < 30
- age between 55-75 years included
- Kelgrenn-Lawrence equal or superior to grade III
- presence of synovitis
Show all 12Show fewer
- patients undergoing knee replacement
- suspension of NSAIDs from one week before the surgical procedure according to the standard clinical practice Healthy subjects from aesthetic plastic surgery
- Subscription of informed consent
- BMI < 30
- age between 18-50 years included
- subjects undergoing liposuction and/or abdominoplasty
Who cannot join
- HCV, HIV, HBV, TPHA infection
- Pregnancy (auto declaration)
Trial locations and contacts
No sites are listed yet.
About this study
Osteoarthritis (OA) is a highly progressive and debilitating joint disease. Recently, it was demonstrated the existence of an important link between OA inflammation and progression of structural changes. Therapy with intra-articular injection of stromal vascular fraction (SVF) holds great promises and its efficacy could be further augmented with the addition of biological adjuvants. In the present project, we aim at demonstrating that human platelet lysate (HPL) increases the intrinsic beneficial properties of SVF on cartilage regeneration and joint environment. Moreover, we want to verify if SVF-conditioned medium (CM) obtained from SVF primed with HPL yields comparable or superior outcomes than whole SVF.
- Being tested
- isolation of waste material and culturing with different supplement culture media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isolation of waste material and culturing with different supplement culture mediaOther
isolation of waste material and culturing with different supplement culture media
| Study group | Role | What they receive |
|---|---|---|
| SVF from healthy subjects from aesthetic plastic surgery | Subjects undergoing plastic surgery as scheduled by clinic routine to obtain waste adipose tissue Receives: Other: isolation of waste material and culturing with different supplement culture media | |
| OA patients | Subjects undergoing prosthetic surgery as scheduled by clinic routine to obtain waste synovium and cartilage Receives: Other: isolation of waste material and culturing with different supplement culture media |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression of trophic-related genes in cartilage samples treated with SVF added or not with HPL
With this project, we expect to demonstrate that HPL increases the beneficial properties of SVF on cartilage regeneration and joint environment. We envision that HPL will increase expression of genes involved in ECM synthesis, thus enhancing cartilage regeneration. Based on previous published data, we will consider as statistical a difference between treated (SVF + HPL) and not treated samples (SVF) of two folds in expression of genes involved in ECM production (e.g. COL2A1, ACAN, SOX9). A fold increase equal to 2 is the minimum value to consider biologically relevant the influence of the treatment compared to a control group in which the gene expression is considered to be equal to 1. If our hypothesis will be confirmed, this will allow to improve the current therapy for OA with a biological adjuvant that reduces disease progression and helps cartilage regeneration.
Measured: surgery as scheduled by clinic routine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study startJan 2020 (estimated)
- Primary completionJul 2021 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assessment of the Trophic and Anti-inflammatory Effect of SVF Added With HPLStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04225481
- Sponsor's protocol ID
- APolLO
- Status last verified
- Jan 2020
- First submitted
- 7 Jan 2020
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Enhanced Therapeutic Effect of Adipose Stromal Vascular Fraction Added With Human Platelet Lysate in Treatment of Osteoarthritis
- ClinicalTrials.gov ID
- NCT04225481
- Acronym / sponsor ID
- APolLO
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- Jan 2020 (estimated)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 13 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Osteoarthritis (OA) is a highly progressive and debilitating joint disease. Recently, it was demonstrated the existence of an important link between OA inflammation and progression of structural changes. Therapy with intra-articular injection of stromal vascular fraction (SVF) holds great promises and its efficacy could be further augmented with the addition of biological adjuvants. In the present project, we aim at demonstrating that human platelet lysate (HPL) increases the intrinsic beneficial properties of SVF on cartilage regeneration and joint environment. Moreover, we want to verify if SVF-conditioned medium (CM) obtained from SVF primed with HPL yields comparable or superior outcomes than whole SVF.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SVF from healthy subjects from aesthetic plastic surgery | – | Other: isolation of waste material and culturing with different supplement culture mediaSubjects undergoing plastic surgery as scheduled by clinic routine to obtain waste adipose tissue |
| OA patients | – | Other: isolation of waste material and culturing with different supplement culture mediaSubjects undergoing prosthetic surgery as scheduled by clinic routine to obtain waste synovium and cartilage |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy subjects undergoing aesthetic plastic surgery or OA patients undergoing prosthetic surgery
Key inclusion criteria (12 listed)
- OA patients
- Subscription of informed consent
- BMI < 30
- age between 55-75 years included
- Kelgrenn-Lawrence equal or superior to grade III
Key exclusion criteria (2 listed)
- HCV, HIV, HBV, TPHA infection
- Pregnancy (auto declaration)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| isolation of waste material and culturing with different supplement culture mediaisolation of waste material and culturing with different supplement culture media | Other | OA patients, SVF from healthy subjects from aesthetic plastic surgery |
Primary outcome
Expression of trophic-related genes in cartilage samples treated with SVF added or not with HPL
Time frame: surgery as scheduled by clinic routine
With this project, we expect to demonstrate that HPL increases the beneficial properties of SVF on cartilage regeneration and joint environment. We envision that HPL will increase expression of genes involved in ECM synthesis, thus enhancing cartilage regeneration. Based on previous published data, we will consider as statistical a difference between treated (SVF + HPL) and not treated samples (SVF) of two folds in expression of genes involved in ECM production (e.g. COL2A1, ACAN, SOX9). A fold increase equal to 2 is the minimum value to consider biologically relevant the influence of the treatment compared to a control group in which the gene expression is considered to be equal to 1. If our hypothesis will be confirmed, this will allow to improve the current therapy for OA with a biological adjuvant that reduces disease progression and helps cartilage regeneration.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Assessment of the Trophic and Anti-inflammatory Effect of SVF Added With HPL, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Silvia Palombella, PhD (02 66214061, silvia.palombella@grupposandonato.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression of trophic-related genes in cartilage samples treated with SVF added or not with HPL (time frame: surgery as scheduled by clinic routine). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.