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Trial record 1 of 3 for:    Stem Cells | Recruiting, Not yet recruiting Studies | Arthritis | within 50 miles of San Francisco, California, U.S.
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Stem Cell and Growth Factor Injury and Arthritis Clinical Research Study

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ClinicalTrials.gov Identifier: NCT03408145
Recruitment Status : Recruiting
First Posted : January 23, 2018
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
The Foundation for Sports Medicine and Arthritis Research

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Device: Hyaluronic Acid Device: Amniotic Tissue Allograft Drug: Saline Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Short-Term Changes in Knee Synovial Fluid Composition Following Intraarticular Implantation of Amniotic Tissue Allograft
Actual Study Start Date : January 4, 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Saline
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
Injection of Saline
Other Names:
  • Sodium Chloride
  • NaCl

Active Comparator: Hyaluronic Acid & Saline
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
Injection of 3x 2.5ml of Hyaluronic Acid
Other Names:
  • Viscosupplementation
  • Supartz

Drug: Saline
Injection of Saline
Other Names:
  • Sodium Chloride
  • NaCl

Active Comparator: Amniotic Tissue & Saline
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
Injection of 1x 1ml of Amniotic Tissue Allograft
Other Names:
  • Stem Cells
  • Growth Factors
  • Palingen InovoFLo

Experimental: Amniotic Tissue & Hyaluronic Acid
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
Injection of 3x 2.5ml of Hyaluronic Acid
Other Names:
  • Viscosupplementation
  • Supartz

Device: Amniotic Tissue Allograft
Injection of 1x 1ml of Amniotic Tissue Allograft
Other Names:
  • Stem Cells
  • Growth Factors
  • Palingen InovoFLo




Primary Outcome Measures :
  1. Knee Joint Chemical Profile [ Time Frame: 1 week ]
    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.


Secondary Outcome Measures :
  1. Pain [ Time Frame: 1 week ]
    Measure self reported pain pre and post injection using Visual Analogue Scale rating 0 to 10, where 0 represents no pain and 10 represents worst imaginable pain.

  2. Function [ Time Frame: 1 week ]
    Measure self reported function pre and post injections using the validated Knee Injury and Osteoarthritis Outcome Score (KOOS).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients age 18 and over
  2. Previous diagnosis of knee OA,
  3. Kellgren-Lawrence grade of 2 - 4
  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
  5. Can give written informed consent

Exclusion Criteria:

  1. Receipt of HA, Platelet Rich Plasma (PRP) or amniotic cell injections in the previous 6 months
  2. Recent history of surgery to the same joint in the previous 3 months
  3. A clinical diagnosis of inflammatory arthritis made by history, examination or serology
  4. 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
  5. A history of chronic alcohol or drug abuse during the six months prior to the study
  6. 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)
  7. Systemic or intra-articular administration, within twenty days prior to the procedure, of any type of corticosteroids, antineoplastic, immune stimulating or immunosuppressive agents
  8. 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
  9. Pregnant females
  10. Subject is unable to understand verbal and/or written English

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03408145


Contacts
Contact: Susan Hennessy, PhD 415-921-1220 research@stoneresearch.org

Locations
United States, California
Stone Research Foundation Recruiting
San Francisco, California, United States, 94123
Contact: Susan Hennessy, PhD    415-921-1220    research@stoneresearch.org   
Sponsors and Collaborators
The Foundation for Sports Medicine and Arthritis Research
Investigators
Principal Investigator: Kevin R Stone, MD The Foundation for Sports Medicine and Arthritis Research (Stone Research Foundation)

Responsible Party: The Foundation for Sports Medicine and Arthritis Research
ClinicalTrials.gov Identifier: NCT03408145     History of Changes
Other Study ID Numbers: SRF-037
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by The Foundation for Sports Medicine and Arthritis Research:
Stem Cell Therapy
Injection
Hyaluronic Acid
Synovial Fluid

Additional relevant MeSH terms:
Arthritis
Osteoarthritis
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Mitogens
Hyaluronic Acid
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents