Trial Outcomes & Findings for Lipogems Prospective Study (NCT NCT03922490)
NCT ID: NCT03922490
Last Updated: 2023-02-10
Results Overview
Questions related to knee pain Scale range: 0-100 points (100 indicating no symptoms and 0 indicating extreme symptoms)
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
2 participants
Primary outcome timeframe
Baseline, 2-Week post-op, 6-Week post-op
Results posted on
2023-02-10
Participant Flow
Participant milestones
| Measure |
Knee Arthroscopy + Adipose Derived Stem Cells (ADSC)
Experimental Group: will undergo diagnostic knee arthroscopy with injection of adipose derived stem cells. Will also carry out all procedures associated with study (Physical Exam, Magnetic Resonance Imaging (MRIs), X-rays, Questionnaires).
Lipogems Device PLUS debridement: Lipogems is the name of the technology used to obtain stem cells from the abdomen, which will then be injected into the knee after knee arthroscopy.
|
Observation Cohort: Knee Arthroscopy
Observational Group: will undergo diagnostic knee arthroscopy (No injection of adipose derived stem cells). Will also carry out all procedures associated with study (Physical Exam, MRIs, X-rays, Questionnaires).
Debridement only: Patients will undergo knee arthroscopy as a standard treatment for their condition but will not receive the fat-derived stem cell treatment nor will undergo any additional procedures.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Due to COVID, recruiting patients was difficult and thus the study has been suspended. To add to that difficulty, RAs have not been permanent and have been leaving prior the agreed time when hired. The target number of participants was never obtained and thus the data set is incomplete.
Baseline characteristics by cohort
| Measure |
Knee Arthroscopy + Adipose Derived Stem Cells (ADSC)
n=2 Participants
Experimental Group: will undergo diagnostic knee arthroscopy with injection of adipose derived stem cells. Will also carry out all procedures associated with study (Physical Exam, Magnetic Resonance Imaging (MRIs), X-rays, Questionnaires).
Lipogems Device PLUS debridement: Lipogems is the name of the technology used to obtain stem cells from the abdomen, which will then be injected into the knee after knee arthroscopy.
|
Observation Cohort: Knee Arthroscopy
Observational Group: will undergo diagnostic knee arthroscopy (No injection of adipose derived stem cells). Will also carry out all procedures associated with study (Physical Exam, MRIs, X-rays, Questionnaires).
Debridement only: Patients will undergo knee arthroscopy as a standard treatment for their condition but will not receive the fat-derived stem cell treatment nor will undergo any additional procedures.
|
Total
n=2 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants • Due to COVID, recruiting patients was difficult and thus the study has been suspended. To add to that difficulty, RAs have not been permanent and have been leaving prior the agreed time when hired. The target number of participants was never obtained and thus the data set is incomplete.
|
—
|
0 Participants
n=5 Participants • Due to COVID, recruiting patients was difficult and thus the study has been suspended. To add to that difficulty, RAs have not been permanent and have been leaving prior the agreed time when hired. The target number of participants was never obtained and thus the data set is incomplete.
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants • Due to COVID, recruiting patients was difficult and thus the study has been suspended. To add to that difficulty, RAs have not been permanent and have been leaving prior the agreed time when hired. The target number of participants was never obtained and thus the data set is incomplete.
|
—
|
2 Participants
n=5 Participants • Due to COVID, recruiting patients was difficult and thus the study has been suspended. To add to that difficulty, RAs have not been permanent and have been leaving prior the agreed time when hired. The target number of participants was never obtained and thus the data set is incomplete.
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants • Due to COVID, recruiting patients was difficult and thus the study has been suspended. To add to that difficulty, RAs have not been permanent and have been leaving prior the agreed time when hired. The target number of participants was never obtained and thus the data set is incomplete.
|
—
|
0 Participants
n=5 Participants • Due to COVID, recruiting patients was difficult and thus the study has been suspended. To add to that difficulty, RAs have not been permanent and have been leaving prior the agreed time when hired. The target number of participants was never obtained and thus the data set is incomplete.
|
|
Age, Continuous
|
56 years
n=5 Participants • Due to COVID, recruiting patients was difficult and thus the study has been suspended. To add to that difficulty, RAs have not been permanent and have been leaving prior the agreed time when hired. The target number of participants was never obtained and thus the data set is incomplete.
|
—
|
56 years
n=5 Participants • Due to COVID, recruiting patients was difficult and thus the study has been suspended. To add to that difficulty, RAs have not been permanent and have been leaving prior the agreed time when hired. The target number of participants was never obtained and thus the data set is incomplete.
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants • Due to COVID, recruiting patients was difficult and thus the study has been suspended. To add to that difficulty, RAs have not been permanent and have been leaving prior the agreed time when hired. The target number of participants was never obtained and thus the data set is incomplete.
|
—
|
1 Participants
n=5 Participants • Due to COVID, recruiting patients was difficult and thus the study has been suspended. To add to that difficulty, RAs have not been permanent and have been leaving prior the agreed time when hired. The target number of participants was never obtained and thus the data set is incomplete.
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants • Due to COVID, recruiting patients was difficult and thus the study has been suspended. To add to that difficulty, RAs have not been permanent and have been leaving prior the agreed time when hired. The target number of participants was never obtained and thus the data set is incomplete.
|
—
|
1 Participants
n=5 Participants • Due to COVID, recruiting patients was difficult and thus the study has been suspended. To add to that difficulty, RAs have not been permanent and have been leaving prior the agreed time when hired. The target number of participants was never obtained and thus the data set is incomplete.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants • Due to COVID, recruiting patients was difficult and thus the study has been suspended. To add to that difficulty, RAs have not been permanent and have been leaving prior the agreed time when hired. The target number of participants was never obtained and thus the data set is incomplete.
|
—
|
0 Participants
n=5 Participants • Due to COVID, recruiting patients was difficult and thus the study has been suspended. To add to that difficulty, RAs have not been permanent and have been leaving prior the agreed time when hired. The target number of participants was never obtained and thus the data set is incomplete.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants • Due to COVID, recruiting patients was difficult and thus the study has been suspended. To add to that difficulty, RAs have not been permanent and have been leaving prior the agreed time when hired. The target number of participants was never obtained and thus the data set is incomplete.
|
—
|
2 Participants
n=5 Participants • Due to COVID, recruiting patients was difficult and thus the study has been suspended. To add to that difficulty, RAs have not been permanent and have been leaving prior the agreed time when hired. The target number of participants was never obtained and thus the data set is incomplete.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • Due to COVID, recruiting patients was difficult and thus the study has been suspended. To add to that difficulty, RAs have not been permanent and have been leaving prior the agreed time when hired. The target number of participants was never obtained and thus the data set is incomplete.
|
—
|
0 Participants
n=5 Participants • Due to COVID, recruiting patients was difficult and thus the study has been suspended. To add to that difficulty, RAs have not been permanent and have been leaving prior the agreed time when hired. The target number of participants was never obtained and thus the data set is incomplete.
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants • Due to COVID, recruiting patients was difficult and thus the study has been suspended. To add to that difficulty, RAs have not been permanent and have been leaving prior the agreed time when hired. The target number of participants was never obtained and thus the data set is incomplete.
|
—
|
2 participants
n=5 Participants • Due to COVID, recruiting patients was difficult and thus the study has been suspended. To add to that difficulty, RAs have not been permanent and have been leaving prior the agreed time when hired. The target number of participants was never obtained and thus the data set is incomplete.
|
PRIMARY outcome
Timeframe: Baseline, 2-Week post-op, 6-Week post-opPopulation: Due to COVID, recruiting patients was difficult and thus the study has been suspended. To add to that difficulty, RAs have not been permanent and have been leaving prior the agreed time when hired. The target number of participants was never obtained and thus the data set is incomplete.
Questions related to knee pain Scale range: 0-100 points (100 indicating no symptoms and 0 indicating extreme symptoms)
Outcome measures
| Measure |
Knee Arthroscopy + Adipose Derived Stem Cells (ADSC)
n=2 Participants
Experimental Group: will undergo diagnostic knee arthroscopy with injection of adipose derived stem cells. Will also carry out all procedures associated with study (Physical Exam, Magnetic Resonance Imaging (MRIs), X-rays, Questionnaires).
Lipogems Device PLUS debridement: Lipogems is the name of the technology used to obtain stem cells from the abdomen, which will then be injected into the knee after knee arthroscopy.
|
Observation Cohort: Knee Arthroscopy
Observational Group: will undergo diagnostic knee arthroscopy (No injection of adipose derived stem cells). Will also carry out all procedures associated with study (Physical Exam, MRIs, X-rays, Questionnaires).
Debridement only: Patients will undergo knee arthroscopy as a standard treatment for their condition but will not receive the fat-derived stem cell treatment nor will undergo any additional procedures.
|
|---|---|---|
|
Change in Knee Injury and Osteoarthritis Outcome (KOOS) Pain Subscale
Baseline
|
52.5 score on a scale
Interval 33.0 to 72.0
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—
|
|
Change in Knee Injury and Osteoarthritis Outcome (KOOS) Pain Subscale
2-Week Post-op
|
69 score on a scale
Interval 69.0 to 69.0
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—
|
|
Change in Knee Injury and Osteoarthritis Outcome (KOOS) Pain Subscale
6-Week Post-op
|
93 score on a scale
Interval 92.0 to 94.0
|
—
|
SECONDARY outcome
Timeframe: Baseline, 2-Week post-op, 6-Week post-opPopulation: Due to COVID, recruiting patients was difficult and thus the study has been suspended. To add to that difficulty, RAs have not been permanent and have been leaving prior the agreed time when hired. The target number of participants was never obtained and thus the data set is incomplete.
Questions related to other knee symptoms other than pain Scale range: 0-100 points (100 indicating no symptoms and 0 indicating extreme symptoms)
Outcome measures
| Measure |
Knee Arthroscopy + Adipose Derived Stem Cells (ADSC)
n=2 Participants
Experimental Group: will undergo diagnostic knee arthroscopy with injection of adipose derived stem cells. Will also carry out all procedures associated with study (Physical Exam, Magnetic Resonance Imaging (MRIs), X-rays, Questionnaires).
Lipogems Device PLUS debridement: Lipogems is the name of the technology used to obtain stem cells from the abdomen, which will then be injected into the knee after knee arthroscopy.
|
Observation Cohort: Knee Arthroscopy
Observational Group: will undergo diagnostic knee arthroscopy (No injection of adipose derived stem cells). Will also carry out all procedures associated with study (Physical Exam, MRIs, X-rays, Questionnaires).
Debridement only: Patients will undergo knee arthroscopy as a standard treatment for their condition but will not receive the fat-derived stem cell treatment nor will undergo any additional procedures.
|
|---|---|---|
|
Change in Knee Injury and Osteoarthritis Outcome (KOOS) Symptoms
Baseline
|
51.5 score on a scale
Interval 39.0 to 64.0
|
—
|
|
Change in Knee Injury and Osteoarthritis Outcome (KOOS) Symptoms
2-Week Post-op
|
75 score on a scale
Interval 75.0 to 75.0
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—
|
|
Change in Knee Injury and Osteoarthritis Outcome (KOOS) Symptoms
6-Week Post-op
|
82.5 score on a scale
Interval 79.0 to 86.0
|
—
|
SECONDARY outcome
Timeframe: Baseline, 2-Week post-op, 6-Week post-opPopulation: Due to COVID, recruiting patients was difficult and thus the study has been suspended. To add to that difficulty, RAs have not been permanent and have been leaving prior the agreed time when hired. The target number of participants was never obtained and thus the data set is incomplete.
Questions related to function in daily living Scale range: 0-100 points (100 indicating no symptoms and 0 indicating extreme symptoms)
Outcome measures
| Measure |
Knee Arthroscopy + Adipose Derived Stem Cells (ADSC)
n=2 Participants
Experimental Group: will undergo diagnostic knee arthroscopy with injection of adipose derived stem cells. Will also carry out all procedures associated with study (Physical Exam, Magnetic Resonance Imaging (MRIs), X-rays, Questionnaires).
Lipogems Device PLUS debridement: Lipogems is the name of the technology used to obtain stem cells from the abdomen, which will then be injected into the knee after knee arthroscopy.
|
Observation Cohort: Knee Arthroscopy
Observational Group: will undergo diagnostic knee arthroscopy (No injection of adipose derived stem cells). Will also carry out all procedures associated with study (Physical Exam, MRIs, X-rays, Questionnaires).
Debridement only: Patients will undergo knee arthroscopy as a standard treatment for their condition but will not receive the fat-derived stem cell treatment nor will undergo any additional procedures.
|
|---|---|---|
|
Change in Knee Injury and Osteoarthritis Outcome (KOOS) Function in Daily Living (ADL)
Baseline
|
56 score on a scale
Interval 37.0 to 75.0
|
—
|
|
Change in Knee Injury and Osteoarthritis Outcome (KOOS) Function in Daily Living (ADL)
2-Week Post-op
|
75 score on a scale
Interval 75.0 to 75.0
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—
|
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Change in Knee Injury and Osteoarthritis Outcome (KOOS) Function in Daily Living (ADL)
6-Week Post-op
|
90.5 score on a scale
Interval 87.0 to 94.0
|
—
|
SECONDARY outcome
Timeframe: Baseline, 2-Week post-op, 6-Week post-opPopulation: Due to COVID, recruiting patients was difficult and thus the study has been suspended. To add to that difficulty, RAs have not been permanent and have been leaving prior the agreed time when hired. The target number of participants was never obtained and thus the data set is incomplete.
Questions related to function in sport and recreation Scale range: 0-100 points (100 indicating no symptoms and 0 indicating extreme symptoms)
Outcome measures
| Measure |
Knee Arthroscopy + Adipose Derived Stem Cells (ADSC)
n=2 Participants
Experimental Group: will undergo diagnostic knee arthroscopy with injection of adipose derived stem cells. Will also carry out all procedures associated with study (Physical Exam, Magnetic Resonance Imaging (MRIs), X-rays, Questionnaires).
Lipogems Device PLUS debridement: Lipogems is the name of the technology used to obtain stem cells from the abdomen, which will then be injected into the knee after knee arthroscopy.
|
Observation Cohort: Knee Arthroscopy
Observational Group: will undergo diagnostic knee arthroscopy (No injection of adipose derived stem cells). Will also carry out all procedures associated with study (Physical Exam, MRIs, X-rays, Questionnaires).
Debridement only: Patients will undergo knee arthroscopy as a standard treatment for their condition but will not receive the fat-derived stem cell treatment nor will undergo any additional procedures.
|
|---|---|---|
|
Change in Knee Injury and Osteoarthritis Outcome (KOOS) Function in Sport and Recreation (Sport/Rec)
Baseline
|
27.5 score on a scale
Interval 10.0 to 45.0
|
—
|
|
Change in Knee Injury and Osteoarthritis Outcome (KOOS) Function in Sport and Recreation (Sport/Rec)
2-week Post-Op
|
45 score on a scale
Interval 45.0 to 45.0
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—
|
|
Change in Knee Injury and Osteoarthritis Outcome (KOOS) Function in Sport and Recreation (Sport/Rec)
6-Week Post-Op
|
57.5 score on a scale
Interval 45.0 to 70.0
|
—
|
SECONDARY outcome
Timeframe: Baseline, 2-Week post-op, 6-Week post-opPopulation: Due to COVID, recruiting patients was difficult and thus the study has been suspended. To add to that difficulty, RAs have not been permanent and have been leaving prior the agreed time when hired. The target number of participants was never obtained and thus the data set is incomplete.
Questions related to knee-related quality of life Scale range: 0-100 points (100 indicating no symptoms and 0 indicating extreme symptoms)
Outcome measures
| Measure |
Knee Arthroscopy + Adipose Derived Stem Cells (ADSC)
n=2 Participants
Experimental Group: will undergo diagnostic knee arthroscopy with injection of adipose derived stem cells. Will also carry out all procedures associated with study (Physical Exam, Magnetic Resonance Imaging (MRIs), X-rays, Questionnaires).
Lipogems Device PLUS debridement: Lipogems is the name of the technology used to obtain stem cells from the abdomen, which will then be injected into the knee after knee arthroscopy.
|
Observation Cohort: Knee Arthroscopy
Observational Group: will undergo diagnostic knee arthroscopy (No injection of adipose derived stem cells). Will also carry out all procedures associated with study (Physical Exam, MRIs, X-rays, Questionnaires).
Debridement only: Patients will undergo knee arthroscopy as a standard treatment for their condition but will not receive the fat-derived stem cell treatment nor will undergo any additional procedures.
|
|---|---|---|
|
Change in Knee Injury and Osteoarthritis Outcome (KOOS) Quality of Life (QOL)
Baseline
|
34.5 score on a scale
Interval 19.0 to 50.0
|
—
|
|
Change in Knee Injury and Osteoarthritis Outcome (KOOS) Quality of Life (QOL)
2-Week Post-op
|
44 score on a scale
Interval 44.0 to 44.0
|
—
|
|
Change in Knee Injury and Osteoarthritis Outcome (KOOS) Quality of Life (QOL)
6-Week Post-op
|
56.5 score on a scale
Interval 50.0 to 63.0
|
—
|
SECONDARY outcome
Timeframe: Baseline, 2-Week post-op, 6-Week post-opPopulation: Due to COVID, recruiting patients was difficult and thus the study has been suspended. To add to that difficulty, RAs have not been permanent and have been leaving prior the agreed time when hired. The target number of participants was never obtained and thus the data set is incomplete.
Questions related to knee function over periods of time (100 indicating no symptoms and 0 indicating extreme symptoms)
Outcome measures
| Measure |
Knee Arthroscopy + Adipose Derived Stem Cells (ADSC)
n=2 Participants
Experimental Group: will undergo diagnostic knee arthroscopy with injection of adipose derived stem cells. Will also carry out all procedures associated with study (Physical Exam, Magnetic Resonance Imaging (MRIs), X-rays, Questionnaires).
Lipogems Device PLUS debridement: Lipogems is the name of the technology used to obtain stem cells from the abdomen, which will then be injected into the knee after knee arthroscopy.
|
Observation Cohort: Knee Arthroscopy
Observational Group: will undergo diagnostic knee arthroscopy (No injection of adipose derived stem cells). Will also carry out all procedures associated with study (Physical Exam, MRIs, X-rays, Questionnaires).
Debridement only: Patients will undergo knee arthroscopy as a standard treatment for their condition but will not receive the fat-derived stem cell treatment nor will undergo any additional procedures.
|
|---|---|---|
|
Change in International Knee Documentation Committee (IKDC) Subjective Knee Form
2-Week Post-op
|
50.6 units on a scale
Interval 50.6 to 50.6
|
—
|
|
Change in International Knee Documentation Committee (IKDC) Subjective Knee Form
6-Week Post-op
|
63.8 units on a scale
Interval 59.8 to 67.8
|
—
|
|
Change in International Knee Documentation Committee (IKDC) Subjective Knee Form
Baseline
|
41.4 units on a scale
Interval 25.3 to 57.5
|
—
|
SECONDARY outcome
Timeframe: Baseline, 2-Week post-op, 6-Week post-opPopulation: Due to COVID, recruiting patients was difficult and thus the study has been suspended. To add to that difficulty, RAs have not been permanent and have been leaving prior the agreed time when hired. The target number of participants was never obtained and thus the data set is incomplete.
Numerical pain rating scale for pain in knee (0-10) (0: no pain - 10: worst pain imaginable)
Outcome measures
| Measure |
Knee Arthroscopy + Adipose Derived Stem Cells (ADSC)
n=2 Participants
Experimental Group: will undergo diagnostic knee arthroscopy with injection of adipose derived stem cells. Will also carry out all procedures associated with study (Physical Exam, Magnetic Resonance Imaging (MRIs), X-rays, Questionnaires).
Lipogems Device PLUS debridement: Lipogems is the name of the technology used to obtain stem cells from the abdomen, which will then be injected into the knee after knee arthroscopy.
|
Observation Cohort: Knee Arthroscopy
Observational Group: will undergo diagnostic knee arthroscopy (No injection of adipose derived stem cells). Will also carry out all procedures associated with study (Physical Exam, MRIs, X-rays, Questionnaires).
Debridement only: Patients will undergo knee arthroscopy as a standard treatment for their condition but will not receive the fat-derived stem cell treatment nor will undergo any additional procedures.
|
|---|---|---|
|
Change in Numerical Pain Rating Scale (NPRS)
Baseline
|
5.5 score on a scale
Interval 3.0 to 8.0
|
—
|
|
Change in Numerical Pain Rating Scale (NPRS)
2-Week Post-op
|
2 score on a scale
Interval 2.0 to 2.0
|
—
|
|
Change in Numerical Pain Rating Scale (NPRS)
6-Week Post-op
|
2.5 score on a scale
Interval 2.0 to 3.0
|
—
|
SECONDARY outcome
Timeframe: Baseline, 2-Week post-op, 6-Week post-opPopulation: Due to COVID, recruiting patients was difficult and thus the study has been suspended. To add to that difficulty, RAs have not been permanent and have been leaving prior the agreed time when hired. The target number of participants was never obtained and thus the data set is incomplete.
Measures frequency of activity in healthiest and most active state during past year Includes four knee functions, each rated 0-4 total scale range 0-16 (higher score indicates more frequent participation/activity)
Outcome measures
| Measure |
Knee Arthroscopy + Adipose Derived Stem Cells (ADSC)
n=2 Participants
Experimental Group: will undergo diagnostic knee arthroscopy with injection of adipose derived stem cells. Will also carry out all procedures associated with study (Physical Exam, Magnetic Resonance Imaging (MRIs), X-rays, Questionnaires).
Lipogems Device PLUS debridement: Lipogems is the name of the technology used to obtain stem cells from the abdomen, which will then be injected into the knee after knee arthroscopy.
|
Observation Cohort: Knee Arthroscopy
Observational Group: will undergo diagnostic knee arthroscopy (No injection of adipose derived stem cells). Will also carry out all procedures associated with study (Physical Exam, MRIs, X-rays, Questionnaires).
Debridement only: Patients will undergo knee arthroscopy as a standard treatment for their condition but will not receive the fat-derived stem cell treatment nor will undergo any additional procedures.
|
|---|---|---|
|
Change in Marx Activity Rating Scale
6-Week Post-op
|
4 score on a scale
Interval 0.0 to 8.0
|
—
|
|
Change in Marx Activity Rating Scale
Baseline
|
3.5 score on a scale
Interval 0.0 to 7.0
|
—
|
|
Change in Marx Activity Rating Scale
2-Week Post-op
|
0 score on a scale
Interval 0.0 to 0.0
|
—
|
SECONDARY outcome
Timeframe: Baseline, 2-Week post-op, 6-Week post-opPopulation: Due to COVID, recruiting patients was difficult and thus the study has been suspended. To add to that difficulty, RAs have not been permanent and have been leaving prior the agreed time when hired. The target number of participants was never obtained and thus the data set is incomplete.
10-item questionnaire with nine 5-point (as well as a single 11-point) rating scales. The results are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. These scores are then standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient. 11-point scale question recalculated to a 5 point scale. only 8 of 10 questions used for scoring calculations (Each sub-score is generated by 4/8 questions) - 4Qs, 5 points each Scale from 0-20 to calculate Global Mental Health Raw Score (higher score means better outcome) Scale from 0-20 to calculate Global Physical Health Raw Score (higher score means better outcome) The raw scores are then standardized to general population using the "T-score": Global physical health t-score range: 16.2-67.7 Global mental health t-score range: 21.2-67.6
Outcome measures
| Measure |
Knee Arthroscopy + Adipose Derived Stem Cells (ADSC)
n=2 Participants
Experimental Group: will undergo diagnostic knee arthroscopy with injection of adipose derived stem cells. Will also carry out all procedures associated with study (Physical Exam, Magnetic Resonance Imaging (MRIs), X-rays, Questionnaires).
Lipogems Device PLUS debridement: Lipogems is the name of the technology used to obtain stem cells from the abdomen, which will then be injected into the knee after knee arthroscopy.
|
Observation Cohort: Knee Arthroscopy
Observational Group: will undergo diagnostic knee arthroscopy (No injection of adipose derived stem cells). Will also carry out all procedures associated with study (Physical Exam, MRIs, X-rays, Questionnaires).
Debridement only: Patients will undergo knee arthroscopy as a standard treatment for their condition but will not receive the fat-derived stem cell treatment nor will undergo any additional procedures.
|
|---|---|---|
|
Change in Patient-Reported Outcomes Measurement Information System Global-10 Short Form (PROMIS-10)
Baseline (Global Physical Health Score)
|
45 T-score
Interval 42.3 to 47.7
|
—
|
|
Change in Patient-Reported Outcomes Measurement Information System Global-10 Short Form (PROMIS-10)
Baseline (Global Mental Health Score)
|
52.15 T-score
Interval 48.3 to 56.0
|
—
|
|
Change in Patient-Reported Outcomes Measurement Information System Global-10 Short Form (PROMIS-10)
2-Week Post-op (Global Physical Health Score)
|
47.7 T-score
Interval 47.7 to 47.7
|
—
|
|
Change in Patient-Reported Outcomes Measurement Information System Global-10 Short Form (PROMIS-10)
2-Week Post-op (Global Mental Health Score)
|
56.0 T-score
Interval 56.0 to 56.0
|
—
|
|
Change in Patient-Reported Outcomes Measurement Information System Global-10 Short Form (PROMIS-10)
6-Week Post-op (Global Physical Health Score)
|
49.25 T-score
Interval 47.7 to 50.8
|
—
|
|
Change in Patient-Reported Outcomes Measurement Information System Global-10 Short Form (PROMIS-10)
6-Week Post-Op (Global Mental Health Score)
|
48.3 T-score
Interval 48.3 to 48.3
|
—
|
Adverse Events
Knee Arthroscopy + Adipose Derived Stem Cells (ADSC)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Observation Cohort: Knee Arthroscopy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place