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Evaluation of Amniotic Fluid Product in Knee Osteoarthritis

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MiMedx

Status

Completed

Conditions

Osteoarthritis of the Knee

Treatments

Other: Amniotic Fluid 2.0ml dose
Other: Amniotic Fluid 4.0ml dose
Other: Placebo Control

Study type

Interventional

Funder types

Industry

Identifiers

NCT02768155
OFORT001

Details and patient eligibility

About

A study evaluating Amniotic Fluid compared to a Saline Placebo Injection in the treatment of subjects with osteoarthritic (OA) knee pain

Enrollment

60 patients

Sex

All

Ages

30+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Subject is 30 years or older.
  2. Subject has a diagnosis of osteoarthritis (OA) defined as Grade 1 to 3 on the Kellgren Lawrence grading scale.
  3. Subject is willing and able provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study.

Exclusion criteria

  1. Subject has active infection at the injection site.
  2. Subject has rheumatoid arthritis, psoriatic arthritis, or have been diagnosed with any other auto-immune disorders that could be the cause of their knee pain.
  3. BMI greater than 45 kg/m2
  4. Subject has received an intra-articular hyaluronic acid (HA) injection for the treatment of OA of the target knee within 3 months prior to screening.
  5. Subject has received a steroid or platelet rich plasma (PRP) injection for the treatment of OA of the target knee within 3 months prior to screening.
  6. Subject has had major surgery, arthroplasty or arthroscopy in the target knee within 26 weeks of treatment or plans to have surgery in the target knee within 180 days of treatment.
  7. Subject is pregnant or plans to become pregnant within 180 days of treatment.
  8. Subject has used an investigational drug, device or biologic within 12 weeks prior to treatment.
  9. Subject has any significant medical condition that, in the opinion of the Investigator, would interfere with protocol evaluation and participation.
  10. Subject has a history of immunosuppressive or chemotherapy in the last 5 years
  11. Subject has autoimmune disease or a known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV
  12. Subject has had prior radiation at the site
  13. Subject is currently taking anticoagulant therapy (excluding Plavix or Aspirin)
  14. Diagnosis of gout in the past 6 month
  15. Subject has a diagnosis of osteoarthritis

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 3 patient groups, including a placebo group

AF 4.0
Experimental group
Description:
Amniotic Fluid 4.0ml dose
Treatment:
Other: Amniotic Fluid 4.0ml dose
AF 2.0
Experimental group
Description:
Amniotic Fluid 2.0ml dose
Treatment:
Other: Amniotic Fluid 2.0ml dose
Placebo
Placebo Comparator group
Description:
Saline Placebo Control
Treatment:
Other: Placebo Control

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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