Early Phase 1 Osteoarthritis Trial, Recruiting NCT06608134 Sponsor: R3 Medical Research Condition: Osteoarthritis
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Early Phase 1 Osteoarthritis Trial, Recruiting

NCT06608134
Recruiting Early Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are over 30 years of age
  • People who have been diagnosed with moderate knee osteoarthritis (Grade II or III on a standard medical scale called the KL scale) in one knee
  • People with a Body Mass Index (BMI) below 50 kg/m²
  • People who rate their knee pain as 4 or higher out of 10 on a standard pain scale
  • Women who are not sexually active, have had a surgical procedure to prevent pregnancy, or have gone through menopause
  • Women who have not yet gone through menopause and have a negative pregnancy test, are using contraception, and do not plan to become pregnant during the study
  • People who are willing and able to provide written consent to participate, in English
  • People who are willing and able to follow all study requirements, attend visits, and communicate in English

Who may not be able to join:

  • People who have taken any pain medications, including anti-inflammatory drugs (such as ibuprofen), within 2 weeks before the study injection date
  • People who use blood-thinning medications, have a history of substance abuse, or are unwilling to agree to report any knee-related medications taken during the study to the research team
  • People who have had any injection into the affected knee (including joint lubricant injections) in the past 6 months
  • People who have had surgery on the affected knee in the past 6 months
  • People who have had a traumatic injury to the affected knee in the past 3 months
  • People who have planned surgery scheduled during the study period
  • People with a history of organ or blood cell transplantation, rheumatoid arthritis, or other conditions where the immune system attacks the body
  • People who are currently taking medications that suppress the immune system
  • People who have been diagnosed with cancer in the past 2 years
  • People who have a current knee infection or have used antibiotics for a knee infection in the past 3 months
  • People who have participated in any other clinical trial or received any experimental treatment (for any health reason) in the past 30 days
  • Women who are breastfeeding, currently pregnant, or plan to become pregnant during the study
  • People for whom standard X-ray or MRI scans are not suitable (confirm with trial site)
  • People with serious neurological, psychological, or psychiatric conditions
  • People who have an active legal claim or compensation case related to an injury or disability
  • People with a known allergy to any of these medications: amphotericin-B, ciprofloxacin, gentamycin, penicillin, or streptomycin

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 16 July 2026
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.

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Trial details

Status
Recruiting
Phase
Early Phase 1
Sponsor
R3 Medical Research
Registry
ClinicalTrials.gov
Start date
1 October 2024
Est. completion
1 October 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

C Reactive Protein; Erythrocyte Sedimentation Rate; Alanine Transaminase; Aspartate Transaminase; Alkaline Phosphatase; Albumin; Creatinine; Blood Urea Nitrogen

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 16 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov