Autologous Conditioned Serum: Functional and Clinical Results

San Donato Group (GSD)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Cartilage Degeneration; Knee Osteoarthritis; Osteoarthritis, Knee

Treatments: Drug: Autologous Conditioned Serum

Study type: Interventional

Funder types: Other

Identifiers

NCT03850080

1ACS

Details and patient eligibility

About

The purpose of this study was to investigate the potential ability of autologous conditioned serum (ACS) to decrease the pain and improve the joint functionality in patients affected by knee osteoarthritis (OA).

Full description

Fifteen patients with clinical and radiological signs of OA of the hip or knee were recruited for this study. Each patient received 4 injections of ACS (Orthokine®) at the site of OA once per week for 4 weeks. Clinical and functional evaluation were performed using VAS scale for pain, WOMAC scale and KSS functional and clinical scores before the first injection, at one week, at two weeks, at three weeks, at one month and at six months. Statistical analysis was done with the Wilcoxon Signed-Rank Test.

Enrollment: 15 patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• knee osteoarthritis >3 months in clinical and radiographic signs
• VAS for pain >50mm

Exclusion criteria

• Hepatitis B
• Hepatitis C
• HIV
• pregnancy
• drug abuse
• other intra-articular injections <6 months
• surgery on affected knee <12 months

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

15 participants in 1 patient group

Autologous Conditioned Serum

Experimental group

Description:

Patients that were deemed admissible to the trial received 1 intra-articular injection of autologous conditioned serum (Orthokine®) for 4 consecutive weeks at the site of OA. These patients were then followed at 1 month and 6 months for clinical and functional evaluation using VAS for pain, WOMAC, and KSS.

Treatment:

Drug: Autologous Conditioned Serum