TerminatedNot Applicable

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

Stopped: The sponsor decided to close the study early due to low patient enrollment and the sponsor no longer pursuing stem cell therapy treatment.

United States14 participantsStarted 2021-05-24

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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
✓. Subject must also meet additional inclusion criteria specific to the targeted joint cohort
✓. Currently Kellgren-Lawrence Grade II, III or IV in the ankle based on X-ray (weight-bearing mortise views with 20⁰ internal rotation)

Exclusion criteria

✕. Subject cannot meet any of the exclusion criteria listed of the targeted joint cohort
✕. 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)

What they're measuring

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).

Timeframe: Up to 2 years

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

Timeframe: Through study completion, up to 3 years

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

Timeframe: 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)

Timeframe: 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)

Timeframe: Through study completion, up to 3 years

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

Timeframe: Through study completion, up to 3 years

Trial details

NCT IDNCT04405297

SponsorSanford Health

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-09-23

View on ClinicalTrials.gov More Knee Osteoarthritis trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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
✓. Subject must also meet additional inclusion criteria specific to the targeted joint cohort
✓. Currently Kellgren-Lawrence Grade II, III or IV in the ankle based on X-ray (weight-bearing mortise views with 20⁰ internal rotation)

Exclusion criteria

✕. Subject cannot meet any of the exclusion criteria listed of the targeted joint cohort
✕. 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)

What they're measuring

Timeframe: Up to 2 years

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

Timeframe: Through study completion, up to 3 years

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

Timeframe: 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)

Timeframe: 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)

Timeframe: Through study completion, up to 3 years

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

Timeframe: Through study completion, up to 3 years