Intra-articular Adipose Tissue Injections for Osteoarthritis

NCT ID: NCT03242707

Last Updated: 2019-10-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2020-12-01

Brief Summary

A new generation of "minimally manipulated" regenerative treatments are being offered at clinics across the country, but there is no strong efficacy data to support their use. The purpose of this study is to estimate the effect size of the treatment by comparing the efficacy of autologous fat to the current standard of care treatment, hyaluronic acid (HA). As a secondary aim, we will test for preliminary evidence of efficacy of autologous fat vs. HA and determine how these treatments effect the biochemical environment of the knee by comparing pre-injection and post-injection synovial fluid biomarker profiles.

Detailed Description

In recent years, fat treatments administered for structural reconstruction, repair, or replacement are being increasingly offered at clinics across the country. These treatments contain both autologous cells that are often referred to as "stem cells" or "MSCs" and extra-cellular matrix (ECM). Cell therapies containing ECM are thought to have the following advantages over treatments prepared using enzymatic digestion: (1) preservation of the stromal vascular niche, which allows time-release of the regenerative factors; (2) release of bioactive molecules by exosomes, which have been demonstrated to be significantly greater in mechanically processed fat than enzymatically processed fat; and (3) maintenance of the structural and morphologic unit, which is thought to increase cell efficacy by making the cells more resilient to the harsh conditions in the recipient environment. Case reports investigating the use of autologous fat treatments show promise, but a number of questions remain unanswered. Agents injected into the joint tend to be quickly cleared from the body and ECM itself has the potential to produce inflammatory signals and induce osteoarthritis.

This study will use a Hyaluronic acid (HA) as an active control, which is the standard of care for pain associated with osteoarthritis. The use of HA as an active control for autologous cell-based therapies is well established and is the best option given the need to aspirate fat tissue from patients who will be receiving the study treatment.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Autologous adipose tissue knee injection

Fat will be removed from the abdomen and processed using the Lipogems device. Approximately 5ml of the microfragmented fat product will be injected into the knee joint.

Group Type: EXPERIMENTAL

Autologous adipose tissue injection

Intervention Type: BIOLOGICAL

20ml to 40ml of subcutaneous adipose tissue will be aspirated from the abdomen. Adipose tissue will be processed using the Lipogems device, a closed-loop processing device used in medical procedures involving the harvesting, concentrating and transferring of autologous adipose tissue.

The resulting fat product will be delivered locally via ultrasound-guided, intra-articular injection.

Hyaluronic Acid knee injection

Hyaluronic Acid - Synvisc-One®: A high molecular weight sodium hyaluronate (HA). HA is an FDA approved, standard of care treatment.

Group Type: ACTIVE_COMPARATOR

Hyaluronic Acid

Intervention Type: DRUG

Synvisc-One® is a high molecular weight sodium hyaluronate.

Interventions

Autologous adipose tissue injection

20ml to 40ml of subcutaneous adipose tissue will be aspirated from the abdomen. Adipose tissue will be processed using the Lipogems device, a closed-loop processing device used in medical procedures involving the harvesting, concentrating and transferring of autologous adipose tissue.

The resulting fat product will be delivered locally via ultrasound-guided, intra-articular injection.

Intervention Type: BIOLOGICAL

Hyaluronic Acid

Synvisc-One® is a high molecular weight sodium hyaluronate.

Intervention Type: DRUG

Other Intervention Names

Lipogems, Microfragmented fat

Eligibility Criteria

Inclusion Criteria

1. Age 45 to 75, inclusive

2. Normal axial alignment

3. X-ray, Kellgren-Lawrence OA grade 2 - 3, inclusive

4. WOMAC-pain: Between 9 and 19, inclusive

5. Willingness to participate all scheduled follow-ups

6. Willingness to refrain from taking NSAIDs, level 2 analgesics, and opioids for the course of the study

7. BMI < 40

Exclusion Criteria

1. Pregnant or lactating

2. Intra-articular injection within 3 months of treatment

3. Inflammatory arthritis

4. Any disease or active drug use that significantly compromises coagulation

5. Significant damage and/or tears of the ACL or other supporting tissues

6. Prior knee surgery in the last 6 months in the knee that will be injected

7. Active tobacco use

8. Active alcohol or substance abuse within 6 months of study entry

9. Known hypersensitivity (allergy) to hyaluronan (sodium hyaluronate) preparations

10. Knee joint infections, skin diseases or infections in the area of the injection site

11. Diabetes

12. Active inhaler use

13. Any medical condition, which in the opinion of the clinical investigator, would interfere with the treatment or outcome evaluation

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Thomas Vangsness

Professor of Orthopaedic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

C.Thomas Vangsness, MD

Role: PRINCIPAL_INVESTIGATOR

Keck School of Medicine of USC

Locations

Keck Medicine of USC

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

William Fang

Role: CONTACT

williahf@usc.edu

323-442-6959

Facility Contacts

William Fang

Role: primary

williahf@usc.edu

323-442-6959

References

Jones IA, Wilson M, Togashi R, Han B, Mircheff AK, Thomas Vangsness C Jr. A randomized, controlled study to evaluate the efficacy of intra-articular, autologous adipose tissue injections for the treatment of mild-to-moderate knee osteoarthritis compared to hyaluronic acid: a study protocol. BMC Musculoskelet Disord. 2018 Oct 24;19(1):383. doi: 10.1186/s12891-018-2300-7.

Reference Type: DERIVED

PMID: 30355323 (View on PubMed)

Other Identifiers

HS-17-00365

Identifier Type: -

Identifier Source: org_study_id