Clinical trial • Not applicable • Musculoskeletal
PRP (platelet-rich plasma) for Knee osteoarthritis
Not applicable trial of PRP (platelet-rich plasma) for Knee osteoarthritis.
Overview
- Trial Therapeutic Area
- Musculoskeletal
- Trial Disease
- Knee osteoarthritis
- Trial Stage
- Not applicable
- Drug Modality
- Cell therapy | Other
Key dates
- Initial CTIS Submission Date
- 20-11-2023
- First CTIS Authorization Date
- 29-05-2024
Trial design
Randomised, prp (intra-articular infiltration), mfat (intra-articular infiltration), prp-mfat (combination intra-articular infiltration)-controlled Not applicable trial across 4 sites in France.
- Randomised
- Yes
- Comparator
- PRP (intra-articular infiltration), MFAT (intra-articular infiltration), PRP-MFAT (combination intra-articular infiltration)
- Target Sample Size
- 180
Recruitment
- Planned Sample Size
- 180
- Recruitment Window Months
- 48
Geography
- Total Number Of Sites
- 4
- Total Number Of Participants
- 180
France
- Earliest CTIS Part Ii Submission Date
- 23-01-2024
- Latest Decision Or Authorization Date
- 03-03-2026
- Processing Time Days
- 770
- Number Of Sites
- 4
- Number Of Participants
- 180
Sites
- Site Name
- Assistance Publique Hopitaux De Marseille
- Department Name
- 13
- Principal Investigator Name
- ROCHWERGER Alexandre
- Principal Investigator Email
- richardalexandre.rochwerger@ap-hm.fr
- Contact Person Name
- ROCHWERGER Alexandre
- Contact Person Email
- richardalexandre.rochwerger@ap-hm.fr
- Site Name
- clinique CHANTECLER
- Department Name
- 13
- Principal Investigator Name
- MARIE-LAURE LOUIS
- Principal Investigator Email
- louis.marielaure@gmail.com
- Contact Person Name
- MARIE-LAURE LOUIS
- Contact Person Email
- louis.marielaure@gmail.com
- Site Name
- clinique juge
- Department Name
- bouches du rhone
- Principal Investigator Name
- marie -laure LOUIS
- Principal Investigator Email
- louis.marielaure@gmail.com
- Contact Person Name
- marie -laure LOUIS
- Contact Person Email
- louis.marielaure@gmail.com
- Site Name
- Hopital Saint Joseph
- Department Name
- 13
- Principal Investigator Name
- SBIHI Jaafar
- Principal Investigator Email
- j.sbihi13@gmail.com
- Contact Person Name
- SBIHI Jaafar
- Contact Person Email
- j.sbihi13@gmail.com
Sponsor
Primary sponsor
- Full Name
- Assistance Publique Hopitaux De Marseille
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- PRP
- Active Substance
- PRP (platelet-rich plasma)
- Modality
- Other
- Routes Of Administration
- Intra-articular
- Route
- Intra-articular
- Investigational Product Name
- MFAT
- Active Substance
- Microfragmented adipose tissue (autologous)
- Modality
- Cell therapy
- Routes Of Administration
- Intra-articular
- Route
- Intra-articular
- Investigational Product Name
- PRP-MFAT
- Active Substance
- Combination of PRP and microfragmented adipose tissue (autologous)
- Modality
- Cell therapy | Other
- Routes Of Administration
- Intra-articular
- Route
- Intra-articular
- Combination Treatment
- Yes
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