New knee shot aims to ease arthritis pain without surgery
NCT ID NCT07580716
First seen Jun 27, 2026 · Last updated Aug 27, 2026 · Updated 2 times
Summary
This study tests an experimental drug called Allocetra, given as a shot into the knee joint, for people aged 64+ with moderate-to-severe knee osteoarthritis. The goal is to see if it reduces pain and improves function better than a placebo. About 270 participants will be followed for 6 months.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 270 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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64 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Participants must meet all of the inclusion criteria listed below to be eligible for the study: 1. Age 64 years or above. 2. Diagnosis of primary femorotibial knee OA. 3. Radiographic evidence of knee OA defined as Kellgren-Lawrence (KL) grade 2 or 3 in the index knee. 4. Participants who are intolerant to, or have failed to adequately respond to at least 2 OA therapies. 5. Index knee pain assessed during the screening period and following wash-out of pain medications. 6. Willingness to abstain from prohibited medications/treatments during the trial. 7. Women who are postmenopausal (≥12 months natural amenorrhea without alternative cause) or surgically sterilized (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy). 8. Male participants with partners of childbearing potential, who are not surgically sterile (vasectomy) for at least 6 months prior to randomization, must use condoms with spermicide in addition to their partner's contraception from randomization and for 90 days after last dose. Exclusion Criteria: Participants will be excluded from the study if they meet any of the following criteria: 1. Severe or end-stage osteoarthritis of the index knee. 2. Clinically significant structural abnormalities or instability of the index knee. 3. Recent major injury, surgical procedure, or intra-articular treatment in the index knee. 4. Any known history of infection or tumor of the index knee, or active infection at the intended injection site. 5. Any known history of inflammatory arthropathy or crystal-deposition disease. 6. Any severe systemic cartilage, bone, or musculoskeletal disorder that may interfere with study outcomes. 7. Clinically significant widespread pain syndromes. 8. Immunosuppressive therapy, clinically significant immunodeficiency, or active infection. 9. Body Mass Index (BMI) \>40 kg/m² 10. Use of medications that may interfere with pain assessment or study outcomes. 11. Known coagulopathy or use of anticoagulant/antiaggregant medication. 12. Significant uncontrolled systemic disease or clinically significant findings on screening laboratory tests or physical examination.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
17 sites in 3 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Centrum Medyczne PLEJADY
NOT_YET_RECRUITINGKrakow, 30-363, Poland
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DC-MED Michal Kowalski S.K. Radom
NOT_YET_RECRUITINGRadom, 26-610, Poland
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DC-MED Michal Kowalski S.K. Swidnica
RECRUITINGSwidnica, 58-100, Poland
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DelRicht Research @ Touro Medical Center
RECRUITINGNew Orleans, Louisiana, 70115, United States
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Etg Justmed
NOT_YET_RECRUITINGWarsaw, 01-696, Poland
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Etg Warszawa
RECRUITINGWarsaw, 02-677, Poland
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Future Medical Research
RECRUITINGLongwood, Florida, 32750, United States
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Medyczne Centrum Hetmańska
RECRUITINGPoznan, 60-218, Poland
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Migre Polskie Centrum
NOT_YET_RECRUITINGWroclaw, 52-210, Poland
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NZOZ Bif-Med. s.c
NOT_YET_RECRUITINGBytom, 41-902, Poland
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Oakland Medical Research
RECRUITINGTroy, Michigan, 48085, United States
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Reumedika sp. z o.o.
NOT_YET_RECRUITINGPoznan, 60-446, Poland
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Sanos Clinic Gandrup
RECRUITINGGandrup, 9362, Denmark
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Sanos Clinic Herlev
RECRUITINGHerlev, 2730, Denmark
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Sanos Clinic Vejle
RECRUITINGVejle, 7100, Denmark
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South Florida Research Phase I-IV
RECRUITINGMiami, Florida, 33166, United States
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Vita Longa Sp. z o.o.
NOT_YET_RECRUITINGKatowice, 40-748, Poland
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