Condition or disease | Intervention/treatment | Phase |
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Osteo Arthritis Knee Degenerative Joint Disease of Knee | Biological: Autologous Adipose-Derived SVF (Stromal Vascular Fraction) Drug: Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | Safety and Feasibility of Intra-articular Transplantation of Autologous Adipose Derived Stromal Vascular Faction (SVF) for Treatment of Osteoarthritis of the Knee |
Actual Study Start Date : | July 1, 2019 |
Estimated Primary Completion Date : | April 1, 2022 |
Estimated Study Completion Date : | March 31, 2024 |
Arm | Intervention/treatment |
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Experimental: SVF (Stromal Vascular Fraction) Group
Subjects with knee osteoarthritis (OA) will receive Autologous Adipose-Derived SVF (Stromal Vascular Fraction) cells
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Biological: Autologous Adipose-Derived SVF (Stromal Vascular Fraction)
60 ml of fat is collected from subjects abdominal wall and SVF is removed from the fat. The SVF is injected into the knee through a needle.
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Placebo Comparator: Placebo Group
Subjects with knee osteoarthritis (OA) will be treated with a placebo
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Drug: Placebo
Saline control that contains no active ingredient
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Ages Eligible for Study: | 40 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Contact: Jennifer Arthurs | 904-953-2000 | Arthurs.Jennifer@mayo.edu |
United States, Florida | |
Mayo Clinic in Florida | Recruiting |
Jacksonville, Florida, United States, 32224 | |
Contact: Jennifer Arthurs 904-953-2000 | |
Contact: Lori Chase 904-953-3464 chase.lori@mayo.edu | |
United States, Minnesota | |
Mayo Clinic in Rochester | Not yet recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Jennifer Arhturs 904-953-2000 |
Principal Investigator: | Shane A Shapiro | Mayo Clinic |
Tracking Information | |||||
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First Submitted Date ICMJE | May 6, 2019 | ||||
First Posted Date ICMJE | May 7, 2019 | ||||
Last Update Posted Date | February 3, 2021 | ||||
Actual Study Start Date ICMJE | July 1, 2019 | ||||
Estimated Primary Completion Date | April 1, 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Adverse Events [ Time Frame: 2 years ] Number of adverse events reported
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Intra-articular Transplantation of Autologous Adipose Derived Stromal Vascular Faction (SVF) for Treatment of Osteoarthritis of the Knee | ||||
Official Title ICMJE | Safety and Feasibility of Intra-articular Transplantation of Autologous Adipose Derived Stromal Vascular Faction (SVF) for Treatment of Osteoarthritis of the Knee | ||||
Brief Summary | Researchers are trying to determine the safety and feasibility of autologous, adipose derived stromal vascular fraction injections in the treatment of knee osteoarthritis | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
30 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | March 31, 2024 | ||||
Estimated Primary Completion Date | April 1, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria
Exclusion Criteria
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Sex/Gender ICMJE |
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Ages ICMJE | 40 Years to 70 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03940950 | ||||
Other Study ID Numbers ICMJE | 18-006909 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Shane A. Shapiro, Mayo Clinic | ||||
Study Sponsor ICMJE | Mayo Clinic | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Mayo Clinic | ||||
Verification Date | February 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |