Guangdong Hongzhi's Knee Osteoarthritis Trial Completes, No Results Posted
NCT06869200 finished this small, single-country device trial in China against a growth-factor kit rival Platelet-Rich Plasma, but the registry carries no WOMAC or VAS data yet.
Executive Summary
- NCT06869200, a 104-patient trial testing a concentrated growth factor (CGF) kit against Platelet-Rich Plasma in knee osteoarthritis, moved to Completed status on 2026-07-07, more than a year after its 2025-07-03 primary completion date, and the registry added a results-first-post-date entry without posting any endpoint values.
- No WOMAC score, VAS pain data, or safety findings appear in the registry, so the trial's actual clinical result on its primary endpoint remains undisclosed even though the study reached Completed status.
- The AppliedXL model's pre-completion read, set on 2025-03-05, put endpoint-met probability at 49.4% and clinical significance at just 2.7%, but that read predates any posted data and cannot be graded against a result that has not been disclosed.
- The trial sits in a crowded field of 80 cell-therapy studies already testing similar regenerative approaches in knee osteoarthritis, so even a favorable result would face a dense landscape of modality-precedent rivals rather than a clear competitive opening.
The status change
ClinicalTrials.gov registry history shows NCT06869200 moved from "Enrolling by invitation" to "Completed" on 2026-07-07, alongside a new entry marking a results-first-post-date. The trial's primary completion date is listed as 2025-07-03 and its overall study completion date as 2025-09-17, meaning the completion status update landed roughly a year after the trial's own primary completion milestone. The registry lists 104 patients enrolled, split 52 to 52 between the CGF arm and a Platelet-Rich Plasma comparator arm.
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
What the trial tests
The study design is a prospective, multicenter, single-blind, randomized, controlled non-inferiority trial: it first tests whether CGF is non-inferior to PRP, and only if that bar is cleared does it proceed to test superiority. The primary endpoint is the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), a composite scale measuring pain, stiffness, and physical function, assessed one month after the first of three weekly intra-articular injections. Secondary endpoints track VAS pain scores and WOMAC at 2 and 3 months.
The data gap
Despite the Completed status, ClinicalTrials.gov has no posted values for the primary WOMAC endpoint, no effect sizes, no p-values, and no disclosed safety profile. This is a non-inferiority design (the treatment must clear a pre-set margin against PRP, not prove superiority outright), and until numeric results post, no claim about whether CGF matched or beat PRP can be supported. The one-month primary endpoint window and 25.6-week effective treatment duration modeled by AppliedXL suggest the biological read should already be available, which sharpens the question of why the numbers are not yet public.
The model's prior read
Going into the trial, the AppliedXL model, dated 2025-03-05, carried a 49.4% probability of the primary endpoint being met and a 76.2% probability tied to regulatory outcome, alongside a clinical significance score of just 2.7%. That clinical significance figure was driven mainly by negative structural signals: near-zero scientific plausibility and mechanism-fit scores, a single-country trial design, and no therapeutic-area track record on file, rather than by any assessment of the drug's actual biology, since the target and mechanism of action are both listed as unknown. That domain mix means the model's read rests on operational and structural features, not mechanism, and should be weighted accordingly.
Competitive landscape
The CGF kit is one of at least 80 cell-therapy trials that have tested regenerative approaches in knee osteoarthritis, spanning mesenchymal stem cells, bone marrow concentrate, Wharton's Jelly derivatives, and platelet-based products. None of the identified comparators, including StromaForte, JointStem, ELIXCYTE, and Allocetra, share this trial's specific target because the target itself is undisclosed, so these are modality-precedent trials rather than direct rivals. No FDA approval exists for a Concentrated Growth Factor product, and no regulatory designations (Breakthrough, Fast Track, Orphan, RMAT) have been granted to this program.
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.