Design and development of Autologous Conditioned Serum production kit

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20260128068684N1

Enrollment

Registered

2026-02-04

Start date

2025-04-19

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

Chronic pain of knee, hip, ankle, shoulder, and low back pain due to disc herniation.

Interventions

Intervention group: In this study, each patient will receive a course of Autologous Conditioned Serum (ACS) injection. The patient’s own blood will be collected and processed using a domestically deve

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Age between 18 and 70 years Presence of musculoskeletal pain or injury, including joint pain, tendon or muscle injuries, or low back pain due to disc herniation Persistence of symptoms for at least 3 months Inadequate response to standard conservative treatments No severe systemic disease or active infection No intra-articular injections or biologic therapies within the past 3 months Ability to comply with follow-up and provision of written informed consent

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Pain score: Assessment of pain intensity using Visual Analog Scale (VAS)Joint function: Evaluation of range of motion and ability to perform daily activitiesQuality of life: Assessment of health-related quality of life changes using standard questionnaires. Timepoint: Clinical assessments and evaluations of joint pain and function will be conducted at the beginning of the study (before serum injection) and at 2, 4, 8 weeks, as well as 6 months after the injection. Method of measurement: Joint pain: Measured using the Visual Analog Scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain.Joint function: Evaluated using joint-specific functional indices, such as WOMAC for knee and hip, SPADI for shoulder, or FAOS for ankle.Safety and adverse events: Any injection-related adverse effects, such as local pain, swelling, or inflammation, will be recorded during follow-up.	—

Measure

Time frame

Pain score: Assessment of pain intensity using Visual Analog Scale (VAS)Joint function: Evaluation of range of motion and ability to perform daily activitiesQuality of life: Assessment of health-related quality of life changes using standard questionnaires. Timepoint: Clinical assessments and evaluations of joint pain and function will be conducted at the beginning of the study (before serum injection) and at 2, 4, 8 weeks, as well as 6 months after the injection. Method of measurement: Joint pain: Measured using the Visual Analog Scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain.Joint function: Evaluated using joint-specific functional indices, such as WOMAC for knee and hip, SPADI for shoulder, or FAOS for ankle.Safety and adverse events: Any injection-related adverse effects, such as local pain, swelling, or inflammation, will be recorded during follow-up.

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Countries

Iran (Islamic Republic of)

Contacts

Public Contactmohammad hossin mohammadi

Shahid Beheshti University of Medical Sciences

drmohammadi@sbmu.ac.ir+98 21 2243 2560

Outcome results

None listed

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