A Disease-based Treatment Study for Diagnosed Osteoarthritis Utilizing Adipose-derived Regenerative Cells

NCT04405297 | Terminated FDA Device

• 1 other identifier: ENDURE
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, multi-location safety and effectiveness study, and data registry of autologous adult ADRCs generated by the Transpose® RT System in subjects with OA in the shoulder, wrist, knee, hip, or ankle.

Conditions

Knee Osteoarthritis; Hip Osteoarthritis; Ankle Osteoarthritis; Shoulder Osteoarthritis; Wrist Osteoarthritis

Keywords

Stem Cells; Adipose-derived regenerative cells; Osteoarthritis; Adipose-derived stem cells; Arthritis; Joint Diseases

Outcome Measures

Primary Outcomes (28)

• Safety as indicated by incidence (%) of unanticipated AEs. All AEs and SAEs will be graded on severity by the Investigator using the National Institutes of Health Common Terminology Criteria for Adverse Events (NIH CTCAE).

  A one-sided binomial test will be used with a significance level of 0.05 to test whether safety was significantly lower than 20%. Each cohort will be analyzed independently.

  Up to 2 years

• Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the knee using PROMIS 10 Global health

  The PROMIS® is a set of participant-centered measures that evaluates and monitors the physical, mental, and social health in adults. Although unknown in osteoarthritis, the PROMIS® 10 Global Heath Survey was developed by the National Institute of Health and validated across a variety of chronic conditions. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. The PROMIS Global-10 is a 10-item patient-reported questionnaire utilizing as 5-point Global Physical Health Score scale ranging from 5="Excellent/Completely" to 1="Poor/Not at all" and a 5-point Global Mental Health scale ranging from 5="Never/None" to 1="Always/Very Severe", as well as a single 11-point question scale from 0="No Pain" to 10="Worst Pain Imaginable".

  Through study completion, up to 3 years

• Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the knee using SF-12v2

  The SF-12v2 is a generic health outcome measurement widely used in chronic illness and chronic pain conditions. The SF-12v2 is a shorter tool that requires less patient and provider effort. Validity and feasibility have been reviewed with demonstration for significance in non-cancer pain patients.Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. SF-12v2 patient-reported questionnaire is utilizes a 5-point scale ranging from "Excellent"/"All of the time" to "None of the time"/"Poor" for both physical and mental questions as well as a 3-point score ranging from "Yes, limited a lot" to "No, not limited at all" for two physical questions.

  Through study completion, up to 3 years

• Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the knee using the Visual Analog Pain Scale (VAS-Pain)

  A VAS instrument measures a characteristic that spans a continuum, cannot be precisely or optimally measured by or would lack sensitivity in distinguishing subtle changes on an ordinal scale. Pain intensity is a characteristic that is commonly measured in this manner. A 100-mm VAS will be administered to assess the subject's experience of joint pain intensity. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. The visual analog scale (VAS) patient-reported questionnaire is a subjective measure for acute and chronic pain utilizing a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain".

  Through study completion, up to 3 years

• Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the knee using the Knee Osteoarthritis Outcome Score (KOOS)

  The Knee injury and Osteoarthritis Outcome Score (KOOS) is a valid, reliable, and responsive outcome measure in total joint replacement (E. T.-L. Roos 2003). KOOS is a self-administered questionnaire that assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. The KOOS's patient-reported questionnaire utilizes 5-point Likert scale, options scored from 0 (No problems) to 4 (Extreme problems).

  Through study completion, up to 3 years

• Efficacy outcomes include changes in the range of motion of the knee (ROM) measurements for the knee

  Ranges include: 0-140 degrees flexion 0 degrees extension

  Through study completion, up to 3 years

• Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the shoulder using PROMIS 10 Global health

  The PROMIS® is a set of participant-centered measures that evaluates and monitors the physical, mental, and social health in adults. Although unknown in osteoarthritis, the PROMIS® 10 Global Heath Survey was developed by the National Institute of Health and validated across a variety of chronic conditions. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. The PROMIS Global-10 is a 10-item patient-reported questionnaire utilizing as 5-point Global Physical Health Score scale ranging from 5="Excellent/Completely" to 1="Poor/Not at all" and a 5-point Global Mental Health scale ranging from 5="Never/None" to 1="Always/Very Severe", as well as a single 11-point question scale from 0="No Pain" to 10="Worst Pain Imaginable".

  Through study completion, up to 3 years

• Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the shoulder using SF-12v2

  The SF-12v2 is a generic health outcome measurement widely used in chronic illness and chronic pain conditions. The SF-12v2 is a shorter tool that requires less patient and provider effort. Validity and feasibility have been reviewed with demonstration for significance in non-cancer pain patients. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. SF-12v2 patient-reported questionnaire is utilizes a 5-point scale ranging from "Excellent"/"All of the time" to "None of the time"/"Poor" for both physical and mental questions as well as a 3-point score ranging from "Yes, limited a lot" to "No, not limited at all" for two physical questions.

  Through study completion, up to 3 years

• Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the shoulder using the Visual Analog Pain Scale (VAS-Pain)

  A VAS instrument measures a characteristic that spans a continuum, cannot be precisely or optimally measured by or would lack sensitivity in distinguishing subtle changes on an ordinal scale. Pain intensity is a characteristic that is commonly measured in this manner. A 100-mm VAS will be administered to assess the subject's experience of joint pain intensity. The visual analog scale (VAS) patient-reported questionnaire is a subjective measure for acute and chronic pain utilizing a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain".

  Through study completion, up to 3 years

• Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the shoulder using American Surgeon and Elbow Surgeon (ASES) measure

  The ASES is a 100-point scale that consists of questions related to pain and activities of daily living. It is comprised of patient self-evaluation section and a physician assessment section.The activities of daily living questionnaire are marked on a four-point ordinal scale that can be converted to a cumulative activities of daily living index. The physician assessment section includes demographic information and assess range of motion, specific physical signs, strength and stability. A shoulder score can be derived from the visual analogue scale score for pain (50%) and the cumulative activities of daily living score (50%). The ASES is a 17-item patient-reported questionnaire utilizing a 10-point pain scale ranging from 0="No pain at all" to 10="Pain as bad as it can be" and a 4-point activities of daily living scale ranging from 0="Unable to do" to 3="Normal"

  Through study completion, up to 3 years

• Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the shoulder using the Oxford Shoulder Score

  The Oxford Shoulder Score (OSS) is validated patient-reported outcome providing researchers and clinicians with a quantitative measure of a patient's response after a surgical and non-surgical shoulder intervention. Developed by the Department of Public Heath in the United Kingdom, the OSS is a 12-item tool used to review patient's pain and function, and is widely utilized in clinical trials. The Oxford Shoulder Score (OSS) is a 12-item patient-reported questionnaire utilizing as a 5-point Likert scale ranging from "None"/No trouble at all" to "Unbearable"/"Impossible to do".

  Through study completion, up to 3 years

• Efficacy outcomes include changes in the range of motion of the shoulder (ROM)

  Ranges include: 0-180 degrees forward flexion 0-150 degrees abduction 30 degrees adduction 70-90 degrees internal rotation 0-90 degrees external rotation

  Through study completion, up to 3 years

• Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the wrist using PROMIS 10 Global health

  The PROMIS® is a set of participant-centered measures that evaluates and monitors the physical, mental, and social health in adults. Although unknown in osteoarthritis, the PROMIS® 10 Global Heath Survey was developed by the National Institute of Health and validated across a variety of chronic conditions. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. The PROMIS Global-10 is a 10-item patient-reported questionnaire utilizing as 5-point Global Physical Health Score scale ranging from 5="Excellent/Completely" to 1="Poor/Not at all" and a 5-point Global Mental Health scale ranging from 5="Never/None" to 1="Always/Very Severe", as well as a single 11-point question scale from 0="No Pain" to 10="Worst Pain Imaginable".

  Through study completion, up to 3 years

• Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the wrist using SF-12v2

  The SF-12v2 is a generic health outcome measurement widely used in chronic illness and chronic pain conditions. The SF-12v2 is a shorter tool that requires less patient and provider effort. Validity and feasibility have been reviewed with demonstration for significance in non-cancer pain patients. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. SF-12v2 patient-reported questionnaire is utilizes a 5-point scale ranging from "Excellent"/"All of the time" to "None of the time"/"Poor" for both physical and mental questions as well as a 3-point score ranging from "Yes, limited a lot" to "No, not limited at all" for two physical questions.

  Through study completion, up to 3 years

• Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the wrist using the Pain Score Analog Scale (VAS-Pain)

  A VAS instrument measures a characteristic that spans a continuum, cannot be precisely or optimally measured by or would lack sensitivity in distinguishing subtle changes on an ordinal scale. Pain intensity is a characteristic that is commonly measured in this manner. A 100-mm VAS will be administered to assess the subject's experience of joint pain intensity. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort.

  Through study completion, up to 3 years

• Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the wrist using the Quick-Dash

  The subject will complete the QuickDASH by scoring each item of the questionnaire with scores between 1 (no difficulty at all) and 5 (unable to do), with higher scores indicating greater disability (Hudak 1996, Kennedy 2011). The QuickDASH questionnaire is considered complete when 10 of the total 11 items are answered. The QuickDASH is an 11 item patient-reported questionnaire utilizing as a 5-point Likert scale ranging from 1="No difficulty"/"None" to 5="Unable to perform"/"Extreme".

  Through study completion, up to 3 years

• Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the wrist using PROMIS-Upper Extremity

  The subject will complete the PROMIS self-report without help from anyone else. The respondents will be given the optimal time needed to capture the most relevant perspective and complete data (e.g., before/after clinician visit or in between visits). All results will be recorded and analyzed in accordance with standard practice. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort.PROMIS- Upper Extremity is a 7-item patient-reported questionnaire utilizing as 5-point scale ranging from 5="Without any difficulty" to 1="Unable to do".

  Through study completion, up to 3 years

• Efficacy outcomes include changes in the range of motion of the wrist (ROM)

  Ranges include: 0-75 degrees flexion 0-70 degrees extension 50 degrees radioulnar deviation arc

  Through study completion, up to 3 years

• Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the ankle using PROMIS 10 Global health

  The PROMIS® is a set of participant-centered measures that evaluates and monitors the physical, mental, and social health in adults. Although unknown in osteoarthritis, the PROMIS® 10 Global Heath Survey was developed by the National Institute of Health and validated across a variety of chronic conditions. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. The PROMIS Global-10 is a 10-item patient-reported questionnaire utilizing as 5-point Global Physical Health Score scale ranging from 5="Excellent/Completely" to 1="Poor/Not at all" and a 5-point Global Mental Health scale ranging from 5="Never/None" to 1="Always/Very Severe", as well as a single 11-point question scale from 0="No Pain" to 10="Worst Pain Imaginable".

  Through study completion, up to 3 years

• Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the ankle using SF-12v2

  The SF-12v2 is a generic health outcome measurement widely used in chronic illness and chronic pain conditions. The SF-12v2 is a shorter tool that requires less patient and provider effort. Validity and feasibility have been reviewed with demonstration for significance in non-cancer pain patients. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. SF-12v2 patient-reported questionnaire is utilizes a 5-point scale ranging from "Excellent"/"All of the time" to "None of the time"/"Poor" for both physical and mental questions as well as a 3-point score ranging from "Yes, limited a lot" to "No, not limited at all" for two physical questions

  Through study completion, up to 3 years

• Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the ankle using the Pain Score on Visual Analog (VAS-Pain)

  VAS instrument measures a characteristic that spans a continuum, cannot be precisely or optimally measured by or would lack sensitivity in distinguishing subtle changes on an ordinal scale. Pain intensity is a characteristic that is Sanford Health Confidential commonly measured in this manner. A 100-mm VAS will be administered to assess the subject's experience of joint pain intensity. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. The visual analog scale (VAS) patient-reported questionnaire is a subjective measure for acute and chronic pain utilizing a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain".

  Through study completion, up to 3 years

• Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the ankle using the Foot and Ankle Disability Index (FADI)

  The Foot and Ankle Disability Index (FADI) is a 34-item questionnaire divided into two sub-scales: the Foot and Ankle Disability Index and the Foot and Ankle Sports Disability index (Hale 2005). Although not one foot and ankle self-reported measure has been determined as the most reliable, FADI is designed to detect deficits in higher functioning subjects and is more sensitive to responses after deliberate intervention. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. The FADI is a 34-item patient-reported questionnaire utilizing a 5-point scale ranging from 0% (most disability) to 100% (least disability), e.g. 0="Unable to do"/"Unbearable" to 4="No difficulty"/"No Pain".

  Through study completion, up to 3 years

• Efficacy outcomes include changes in the range of motion of the ankle (ROM)

  Ranges include: 0-40 degrees plantar flexion 0-20 degrees dorsiflexion 0-30 degrees inversion 0-20 degrees eversion

  Through study completion, up to 3 years

• Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the hip using PROMIS 10 Global health

  The PROMIS® is a set of participant-centered measures that evaluates and monitors the physical, mental, and social health in adults. Although unknown in osteoarthritis, the PROMIS® 10 Global Heath Survey was developed by the National Institute of Health and validated across a variety of chronic conditions. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. The PROMIS Global-10 is a 10-item patient-reported questionnaire utilizing as 5-point Global Physical Health Score scale ranging from 5="Excellent/Completely" to 1="Poor/Not at all" and a 5-point Global Mental Health scale ranging from 5="Never/None" to 1="Always/Very Severe", as well as a single 11-point question scale from 0="No Pain" to 10="Worst Pain Imaginable".

  Through study completion, up to 3 years

• Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the hip using SF-12v2

  The SF-12v2 is a generic health outcome measurement widely used. The Bonferroni adjustment for multiple testing correction will be used within each cohort. SF-12v2 patient-reported questionnaire is utilizes a 5-point scale ranging from "Excellent"/"All of the time" to "None of the time"/"Poor" for both physical and mental questions as well as a 3-point score ranging from "Yes, limited a lot" to "No, not limited at all" for two physical questions. The PROMIS Global-10 is a 10-item patient-reported questionnaire utilizing as 5-point Global Physical Health Score scale ranging from 5="Excellent/Completely" to 1="Poor/Not at all" and a 5-point Global Mental Health scale ranging from 5="Never/None" to 1="Always/Very Severe", as well as a single 11-point question scale from 0="No Pain" to 10="Worst Pain Imaginable".

  Through study completion, up to 3 years

• Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the hip using Pain Score on Visual Analog Scale (VAS-Pain)

  A VAS instrument measures a characteristic that spans a continuum, cannot be precisely or optimally measured by or would lack sensitivity in distinguishing subtle changes on an ordinal scale. Pain intensity is a characteristic that is commonly measured in this manner. A 100-mm VAS will be administered to assess the subject's experience of joint pain intensity. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. The visual analog scale (VAS) patient-reported questionnaire is a subjective measure for acute and chronic pain utilizing a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain".

  Through study completion, up to 3 years

• Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the hip using the Hip Disability Osteoarthritis Outcome Score (HOOS)

  The HOOS is a patient-administered questionnaire consisting of 40 items across five subscales: Pain (10 items), Symptoms (5 items), Activity of Daily Living (17 items), Sport and Recreation Function (4 items) and Hip Related Quality of Life (4 items). The HOOS is scored on a Likert scale of 0 to 4 (no, mild, moderate, severe and extreme) with a total score is calculated by using a worst to best scale from 0 to 100, with 100 indicating no symptoms and 0 indicating extreme symptoms, with higher scores representing better function.

  Through study completion, up to 3 years

• Efficacy outcomes include changes in the range of motion of the knee (ROM) measurements for the hip

  Ranges include: 0-125 degrees flexion 115-0 degrees extension 0-15 degrees hyperextension 0-45 degrees abduction 0-20 degrees adduction

  Through study completion, up to 3 years

Secondary Outcomes (1)

• The secondary objective is to create a data registry for future research on ADRC use for OA

  Through study completion, up to 3 years

Other Outcomes (1)

• A small volume of each subject's ADRC will be processed and stored for future research.

  Through study completion, up to 3 years

Study Arms (5)

Hip Osteoarthritis

Subjects will receive autologous adipose-derived regenerative stem cells into their affected hip joint.

Device: Adipose-derived regenerative cells

Knee Osteoarthritis

Subjects will receive autologous adipose-derived regenerative stem cells into their affected knee joint.

Device: Adipose-derived regenerative cells

Ankle Osteoarthritis

Subjects will receive autologous adipose-derived regenerative stem cells into their affected ankle joint.

Device: Adipose-derived regenerative cells

Shoulder Osteoarthritis

Subjects will receive autologous adipose-derived regenerative stem cells into their affected shoulder joint.

Device: Adipose-derived regenerative cells

Wrist Osteoarthritis

Subjects will receive autologous adipose-derived regenerative stem cells into their affected wrist joint.

Device: Adipose-derived regenerative cells

Interventions

Adipose-derived regenerative cells DEVICE

Adipose-derived regenerative cells will be obtained from a small-volume lipoaspirate procedure. The lipoaspirate will then be enzymatically digested to produce a stromal vascular fraction (SVF) that will be injected into the targeted joint.

Ankle Osteoarthritis; Hip Osteoarthritis; Knee Osteoarthritis; Shoulder Osteoarthritis; Wrist Osteoarthritis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The focus of this study is to investigate the therapeutic benefit of autologous ADRCs in patients with OA in various joints. The ENDURE study allows subjects at Sanford Health and in the United States access to adipose-derived regenerative cells while reviewing safety for subjects with knee, shoulder, hip, ankle and wrist OA, using a more pragmatic and standard clinical approach.

You may qualify if:

• Men and women age 18 or older
• Clinical and radiographic diagnosis of OA in one of the following areas: Ankle, Hip, Knee, Shoulder, or Wrist
• Continued OA pain in the targeted joint despite conservative measures (per treating provider's discretion)
• Average daily VAS Pain Score ≥3
• Understand and provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization prior to initiation of any study-specific procedures
• On physical exam. subject appears to have adequate adipose tissue for liposuction
• Ankle Cohort:
• Currently Kellgren-Lawrence Grade II, III or IV in the ankle based on X-ray (weight-bearing mortise views with 20⁰ internal rotation)
• Ankle pain for at least 6 months, despite conservative treatment or inability to tolerate the side effects of medications
• Normal activity level, not bedridden or confined to a wheelchair, able to walk 30 meters without the aid of a walker, crutches or cane
• Hip Cohort:
• \. Hip OA diagnosed on x-ray and/or Magnetic Resonance Imaging (MRI) (Tӧnnis grade 1, 2, or 3)
• Knee Cohort:
• Kellgren-Lawrence system of Grade II, III, or IV
• Subject may have concomitant patellofemoral but they must have stage II or higher generalized knee OA

You may not qualify if:

• Viscosupplementation within 6 months of screening in the targeted joint
• Other Biologic Injection (Platelet Rich Plasma (PRP) or stem cell) within 6 months in the targeted joint
• Surgery in the targeted joint within the past 6 months (either open or scope)
• Planned/anticipated surgery of the targeted joint during study participation
• Systemic or intra-articular injection of corticosteroids in any joint within 3 months before screening (re-screening allowed once this criteria is met)
• Females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the duration of the study. Oral, injected or implanted hormonal contraceptive, barrier methods (condom or diaphragm with spermicide), intrauterine device, surgical sterilization, transdermal delivery, congenital sterility or sexual abstinence are considered acceptable forms of birth control. If sexually active, the subject must have been using one of the accepted birth control methods at least one month prior to study entry.
• Part of a vulnerable population per Office for Human Research Protections (OHRP) definition (pregnant women and breast-feeding women, cognitively impaired, prisoners, etc.)
• Unwilling to discontinue the use of Non-Steroidal Anti-Inflammatory (NSAID)s for 7 calendar days prior to the procedure
• Unwilling to discontinue NSAIDS for 5 calendar days after procedure
• Insufficient amount of subcutaneous tissue to allow recovery of at least 100mL of lipoaspirate
• Diagnosed musculoskeletal cancer or any diagnosed cancer, other than musculoskeletal if not on long term remission (e.g. at least 5 years or negative biopsy at last exam), except basal cell carcinoma
• Have received chronic (more than 7 consecutive days) treatment with systemic corticosteroids at a dose equivalent to prednisone ≥ 10 mg/day within 14 days prior to an injection procedure.
• History of, or ongoing, autoimmune disorder that requires treatment with an immunosuppressive medication
• Subjects who have a documented history or presence of inflammatory arthritis, rheumatoid arthritis, and sepsis in the treatment site
• History of bleeding disorders or inflammatory joint disease

Sponsors & Collaborators

• Sanford Health: lead

Study Sites (1)

Sanford Orthopedics and Sports Medicine

Sioux Falls, South Dakota, 57104, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

After completion of the product release criteria testing, a small amount of the sample will be processed and stored for future research. These retained samples will be used for future research. Future research results will not be returned to the study participants or investigators.

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip; Osteoarthritis; Arthritis; Joint Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• David A. Pearce, PhD

  Sanford Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2020
• First Posted: May 28, 2020
• Study Start: May 24, 2021
• Primary Completion: September 23, 2024
• Study Completion: September 23, 2024
• Last Updated: October 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)