| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| 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 |
|---|---|
|
Experimental: SVF (Stromal Vascular Fraction) Group
Subjects with knee osteoarthritis (OA) will receive Autologous Adipose-Derived SVF (Stromal Vascular Fraction) cells
|
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.
|
|
Placebo Comparator: Placebo Group
Subjects with knee osteoarthritis (OA) will be treated with a placebo
|
Drug: Placebo
Saline control that contains no active ingredient
|
| 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 | |||||
|---|---|---|---|---|---|
| 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 | ||||
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* 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 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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