Clinical trial NCT03014401: The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis
Official title: The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: stem cell
knee pain
osteoarthritis
arthritis
ADSC
fat stem cell
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Stanford University
First posted: 2017-01-09
Enrollment: 29
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the clinical and functional outcomes of patients with mild to moderate arthroscopically confirmed osteoarthritis between the following two groups:

1. Partial fat pad harvest with Adipose-Derived Stem Cell (ADSC) transplantation with standard arthroscopic treatment consisting of: partial meniscectomy, cartilage stabilization, loose body removal and selective synovectomy.
2. Standard arthroscopic treatment (above) without cell transplant.

Detailed description: Adipose-derived stem cells (ADSC) may be beneficial to patients with OA because they may differentiate into chondrocytes, promote endogenous tissue repair, and have potent anti-inflammatory properties.

Early studies show promising clinical results using ADSCs to treat patients with osteoarthritis, but no clinical trials have been completed comparing cellular therapy to standard arthroscopic treatment.

The investigators aim to determine whether ADSC transplantation as adjuvant therapy in patients with arthroscopic findings of mild to moderate arthritis will result in improved clinical outcomes scores at one and two-year follow-up compared to standard arthroscopic treatment.

Eligibility criteria: Inclusion Criteria:

* Age between 35 and 70 years-old
* Patient is scheduled to undergo one or a combination of the following procedures:

  * Meniscal debridement or partial menisectomy
  * Meniscal repair that does not necessitate a different postoperative protocol from meniscal debridement or partial menisectomy
  * Removal of loose bodies
  * Chondroplasty
  * Synovectomy
  * Soft tissue releases for flexion or extension contracture.
* Diagnosis of pre-existing mild to moderate osteoarthritis of the medial or lateral femoral condyle (Kellgren-Lawrence Grade 2 or 3)
* \< 6 months of knee pain or \< 6 months of a significant exacerbation of existing knee pain
* Physical examination findings consistent with the proposed surgical procedure.
* Failure of conservative therapy consisting of a minimum of 6 weeks of physical therapy and trial of anti-inflammatory medications, with or without concomitant bracing and/or injections

Exclusion Criteria:

* Age \< 35 or \> 70 years old
* Radiographs demonstrating either no, little or severe osteoarthritis (Kellgren-Lawrence Grade 0, 1 or 4)
* Previous injury or surgery to the infrapatellar fat pad (assessed by MRI)
* Patient scheduled to undergo any concomitant surgical procedures with the exception of:

  * Meniscal debridement or partial menisectomy
  * Meniscal repair that does not necessitate a different postoperative protocol from meniscal debridement or partial menisectomy
  * Removal of loose bodies
  * Chondroplasty
  * Synovectomy
  * Soft tissue releases for flexion or extension contracture
* Prior surgery on ipsilateral knee involving cartilage regeneration (microfracture, Autologous Chondrocyte Implantation, etc) or meniscal transplant/implant
* Previous arthroscopy within 1 year
* Subchondral edema

Primary outcomes:
measure: Postoperative KOOS (Knee Injury and Osteoarthritis Outcome Score) score 24 months following surgery
timeFrame: The study will end after 24 month follow-up is completed in all participants.
Secondary outcomes:
measure: Tegner score
timeFrame: 6, 12, 24 months
measure: Lysholm score
timeFrame: 6, 12, 24 months
measure: VR-12
timeFrame: 6, 12, 24 months
Other outcomes:
measure: MRI scans -
timeFrame: 1, 12, 24 months
Locations:
city: Santa Monica
country: United States
facility: Kerlan Jobe Orthopedic Institute
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Denver
country: United States
facility: UC Health Steadman Hawkins Clinic - Denver Inverness
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Jason L Dragoo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Seth L Sherman, MD
role: PRINCIPAL_INVESTIGATOR
References: