Stem Cell and Growth Factor Injury and Arthritis Clinical Research Study

NCT03408145 | Completed DMC FDA Device

• 1 other identifier: SRF-037
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators believe that amniotic tissue allografts may be an effective modality to treat osteoarthritis (OA) of the knee. One important mechanism of action may be stimulation of the synovial cells to increase production of endogenous hyaluronic acid (HA). A second mechanism may be the increase in the anabolic factors and a decrease in degenerative factors in the joint. The Investigators propose to quantify the concentration of HA and selected anabolic and degradative factors in synovial fluid aspirate pre and post implantation. While the treatment provided is designed to provide pain relief for symptoms, the purpose of this study is to learn more information about the impact of amniotic tissue allografts on inflammatory markers and growth factors in the knee joint.

Conditions

Osteoarthritis, Knee

Keywords

Stem Cell Therapy; Injection; Hyaluronic Acid; Synovial Fluid

Outcome Measures

Primary Outcomes (1)

• Knee Joint Chemical Profile

  Evaluation of ELISA assay on synovial fluid aspirated pre and post study injection to ascertain the chemical profile of the joint for specific targets which include hyaluronic acid concentration, protein content and for increased levels of the following anabolic factors,IL1ra, TMP1, TMP2, HA, and IGF1 as well as decreased levels of the following degradative factors, IL-1, TNF-alpha, IL-10, MMP-2, MMP-9, TGF-beta5.

  1 week

Secondary Outcomes (2)

• VAS Pain scale

  1 week

• Function

  1 week

Study Arms (4)

Saline

PLACEBO COMPARATOR

The investigators aspirate 1-2ml of Synovial Fluid from the knee joint prior to administering a series of four injections (2.5ml, 2.5ml, 2.5ml and 1ml of Saline) comprising a total volume of 8.5ml fluid during one procedure.

Drug: Saline

Hyaluronic Acid & Saline

ACTIVE COMPARATOR

The investigators aspirate 1-2ml of Synovial Fluid from the knee joint prior to administering a series of four injections (2.5ml, 2.5ml, 2.5ml of Hyaluronic Acid and 1ml Saline) comprising a total of 8.5mL fluid during one procedure.

Device: Hyaluronic Acid; Drug: Saline

Amniotic Tissue & Saline

ACTIVE COMPARATOR

The investigators aspirate 1-2ml of Synovial Fluid from the knee joint prior to administering a series of four injections (2.5ml, 2.5ml, 2.5ml of Saline and 1ml Amniotic Tissue Allograft) comprising a total of 8.5mL fluid during one procedure.

Device: Amniotic Tissue Allograft

Amniotic Tissue & Hyaluronic Acid

EXPERIMENTAL

The investigators aspirate 1-2ml of Synovial Fluid from the knee joint prior to administering a series of four injections (2.5ml, 2.5ml, 2.5ml of Hyaluronic Acid and 1ml Amniotic Tissue Allograft) comprising a total of 8.5mL fluid during one procedure.

Device: Hyaluronic Acid; Device: Amniotic Tissue Allograft

Interventions

Hyaluronic Acid DEVICE

Injection of 3x 2.5ml of Hyaluronic Acid

Also known as: Viscosupplementation, Supartz

Amniotic Tissue & Hyaluronic Acid; Hyaluronic Acid & Saline

Amniotic Tissue Allograft DEVICE

Injection of 1x 1ml of Amniotic Tissue Allograft

Also known as: Stem Cells, Growth Factors, Palingen InovoFLo

Amniotic Tissue & Hyaluronic Acid; Amniotic Tissue & Saline

Saline DRUG

Injection of Saline

Also known as: Sodium Chloride, NaCl

Hyaluronic Acid & Saline; Saline

Eligibility Criteria

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

You may qualify if:

• Patients age 18 and over
• Previous diagnosis of knee OA,
• Kellgren-Lawrence grade of 2 - 4
• Minimum Visual Analogue Scale (VAS) pain score of 3 on a scale of 0 - 10 where 0 is no pain and 10 is the highest level of pain
• Can give written informed consent

You may not qualify if:

• Receipt of HA, Platelet Rich Plasma (PRP) or amniotic cell injections in the previous 6 months
• Recent history of surgery to the same joint in the previous 3 months
• A clinical diagnosis of inflammatory arthritis made by history, examination or serology
• An active or latent infection of the affected knee joint or any other systemic infection currently under treatment or treated within the previous 3 months
• A history of chronic alcohol or drug abuse during the six months prior to the study
• Clinically documented acute or unstable concomitant disease, other than the condition to be treated in this study that might be a confounding reason for the presence of pathogens (i.e. renal, hepatic, cardiac, endocrine, hematologic, autoimmune, metabolic bone, crystal deposition, severe degenerative joint, neoplastic diseases)
• Systemic or intra-articular administration, within twenty days prior to the procedure, of any type of corticosteroids, antineoplastic, immune stimulating or immunosuppressive agents
• Participation in any other investigational drug or device trial during the 30 days prior to screening visit or who will receive such a drug or device during the course of this study
• Pregnant females
• Subject is unable to understand verbal and/or written English

Sponsors & Collaborators

• The Stone Research Foundation for Sports Medicine and Arthritis: lead

Study Sites (1)

Stone Research Foundation

San Francisco, California, 94123, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Viscosupplementation; Sodium Chloride

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Injections, Intra-Articular; Injections; Drug Administration Routes; Drug Therapy; Therapeutics; Orthopedic Procedures; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Kevin R Stone, MD

  The Foundation for Sports Medicine and Arthritis Research (Stone Research Foundation)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: January 23, 2018
• Study Start: January 4, 2018
• Primary Completion: October 10, 2019
• Study Completion: October 10, 2020
• Last Updated: March 25, 2021

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)