This is an observational study to evaluate the safety and effectiveness of marketed product StemOne injection in patients with Osteoarthritis of Knee.

Active Post Marketing Surveillance Study to Evaluate the Safety and Effectiveness of StemOneTM in patients with Osteoarthritis (OA) of Knee. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2025/03/082846

Enrollment

200

Registered

2025-03-19

Start date

Unknown

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Health Condition 1: M179- Osteoarthritis of knee, unspecified

Interventions

Intervention1: StemOneTM : intra-articular injection of (25 million cells in 1ml of CryoStor CS5 + 1ml PlasmaLyte-A), followed by 2 ml Hyalgan (Sodium Hyaluronate injection). Pretreatment : Appropr

Eligibility

Inclusion criteria

Inclusion criteria: 1Written, signed, dated informed consent obtained from patients 2Patients of either sex of 40 years and above with Grade 2 & Grade 3 Osteoarthritis of knee based on the Kellgren and Lawrence radiographic criteria Patients with BMI <30kgm2

Exclusion criteria

Exclusion criteria: Patients with known hypersensitivity to hyaluronan products or animal sera or constituents of StemOneTM

Design outcomes

Primary

Measure	Time frame
Safety evaluation assessments: 1.Evaluation of Adverse events 2.Evaluation of drug related adverse events 3.Occurrence of clinical abnormality at the site of injection, vital signs and physical examinations and laboratory investigations 4.VAS Score 5.Assessment of Biomarkers CTX II (Urine) and IL-10 (Serum) 6.MRI of Knee joint (T2 mapping), cartilage volume & cartilage thickness (to be done in consenting patients only)Timepoint: At 1, 3, 6,12,18, 24, 30 & 36 months MRI at Visit 1 (Baseline) & Visit 10 (24 Months)	—

Measure

Time frame

Safety evaluation assessments: 1.Evaluation of Adverse events 2.Evaluation of drug related adverse events 3.Occurrence of clinical abnormality at the site of injection, vital signs and physical examinations and laboratory investigations 4.VAS Score 5.Assessment of Biomarkers CTX II (Urine) and IL-10 (Serum) 6.MRI of Knee joint (T2 mapping), cartilage volume & cartilage thickness (to be done in consenting patients only)Timepoint: At 1, 3, 6,12,18, 24, 30 & 36 months MRI at Visit 1 (Baseline) & Visit 10 (24 Months)

—

Secondary

Measure	Time frame
NATimepoint: NA	—

Countries

India

Contacts

Public ContactDr Pawan Kumar Gupta

Stempeutics Research Pvt Ltd

pawan.gupta@stempeutics.com8025028103

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026