The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis

University of Colorado Denver (CU Denver)

Status: Enrolling

Conditions: Knee Osteoarthritis

Treatments: Procedure: Arthroscopic debridement with stem cell transplantation; Procedure: Arthroscopic debridement only

Study type: Interventional

Funder types: Other

Identifiers

NCT03014401

19-2893

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 estimated patients

Sex: All

Ages: 35 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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29 participants in 2 patient groups

Stem Cells

Experimental group

Description:

Fat pad harvest with stem cell transplantation and standard arthroscopic debridement.

Treatment:

Procedure: Arthroscopic debridement with stem cell transplantation

Placebo

Active Comparator group

Description:

Standard arthroscopic debridement with fat pad harvest WITHOUT stem cell transplantation

Treatment:

Procedure: Arthroscopic debridement only