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Management of bone loss by surgery using synthetic ceramics loaded with stem cells

Treatment of large segmental bone defects with custom made triphasic hydroxyapaptite scaffolds loaded with mesenchymal stem cells in children.

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/09/005027
Enrollment
10
Registered
2014-09-16
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: M865- Other chronic hematogenous osteomyelitis Health Condition 2: M845- Pathological fracture in neoplastic disease Health Condition 3: null- Segmental bone defects following resection of tumor, infection or trauma in children

Interventions

Intervention1: operative treatment of bone loss with scaffolds loaded with stem cells: Bone defect will be freshened up after excising the sclerotic ends. The seeded scaffold loaded with directed mese

Sponsors

Department of Biotechnology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children over one year of age with large bone defects following tumor resection post-traumatic bone loss, post infective bone loss or loss due to any other causes with a good intact soft tissue envelope and giving consent for the experimental treatment

Exclusion criteria

Exclusion criteria: i) Active infection ii) Poor soft tissue cover iii) Patients who are not likely to come for a full review process of 2 years iv) Patients who are not likely to survive for 2 years due to their disease process

Design outcomes

Primary

MeasureTime frame
Radiographic union of the grat at both ends Any major adverse eventTimepoint: follow ups at 2 weeks after surgery. seusequently 2 months, 3 months, 6 months, 9 months, one year, one and half years and 2 years

Secondary

MeasureTime frame
1.To assess the osteoblastic activity in serum. 2. pixel assessment and CT assessemt after implant removalTimepoint: Bone specific alkaline phosphatase at 2weeks and 2 months

Countries

India

Contacts

Public ContactDr Vrisha Madhuri

Christian Medical College Vellore

madhuriwalter@cmcvellore.ac.in04162282081

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026