Assessment of the safety and benefits of joint injections with regenerative therapies in people with hemophilic arthropathy

Evaluation of the efficacy and safety of intra-articular infiltration of regenerative therapies in hemophilic arthropathy

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

REBEC

Registry ID

RBR-22xgxrw

Enrollment

100

Registered

2026-05-06

Start date

2026-03-23

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemophilia A

Interventions

This is a prospective, randomized, parallel, controlled clinical trial with four intervention arms, organized into two independent randomized sub-studies. A total sample size of 100 patients is estima

Eligibility

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Adults aged 18 years or older; diagnosis of hemophilia A or B (moderate or severe); presence of hemophilic arthropathy in at least one joint (knee, ankle, elbow, shoulder, or hip); regular follow-up at a hemophilia treatment center; ability to provide informed consent; availability for follow-up assessments at baseline, 3 and 6 months

Exclusion criteria

Exclusion criteria: Presence of active local or systemic infection (including septic arthritis or cellulitis) at the time of intervention; recent orthopedic procedure in the target joint during the study period; immunosuppression; pregnancy or suspected pregnancy; significant joint instability or suspected fracture in the target joint; withdrawal of consent during the study

Design outcomes

Primary

Measure	Time frame
It is expected to find an improvement in joint pain assessed by the Visual Analog Scale (VAS) from baseline to 6 months after the intervention	—

Secondary

Measure	Time frame
It is expected to find an improvement in functional capacity assessed by the 6-Minute Walk Test (6MWT) from baseline to 3 and 6 months;It is expected to find an increase in muscle strength assessed by handgrip dynamometry from baseline to 3 and 6 months;It is expected a positive change in joint imaging scores (Pettersson and HEAD-US) from baseline to 6 months;It is expected to be established the efficacy and efficacy and safety of the procedure, with a low incidence of adverse effects;It is expected to characterize the proteomic profile of PRP and synovial fluid to better understand the biological mechanisms involved in tissue and inflammatory responses	—

Measure

Time frame

It is expected to find an improvement in functional capacity assessed by the 6-Minute Walk Test (6MWT) from baseline to 3 and 6 months;It is expected to find an increase in muscle strength assessed by handgrip dynamometry from baseline to 3 and 6 months;It is expected a positive change in joint imaging scores (Pettersson and HEAD-US) from baseline to 6 months;It is expected to be established the efficacy and efficacy and safety of the procedure, with a low incidence of adverse effects;It is expected to characterize the proteomic profile of PRP and synovial fluid to better understand the biological mechanisms involved in tissue and inflammatory responses

—

Countries

Contacts

Public ContactSylvia Thomas

Universidade Federal do Rio de Janeiro

sylviahemato@gmail.com+55(21)992552136

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Jun 11, 2026