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Stem Cell Application in Nerve Transfer Surgery for Traumatic Brachial Plexus Injury: A Pilot Trial on Safety and Functional Outcomes

Feasibility Safety and Early Functional Outcomes of Intra operative Bone Marrow Derived Stem Cell (BMSC) Application Versus Conventional Repair Alone in Nerve Transfer Surgery for Traumatic Brachial Plexus Injury A Randomised Double Blind Pilot Trial - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/097065
Enrollment
24
Registered
2025-11-07
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: G540- Brachial plexus disorders

Interventions

Intervention1: distal nerve injection: 1ml of cell suspension will be injected into the distal nerve using 27G needle intraoperatively single sitting at time of surgery. total duration : single intra

Sponsors

Department of burns plastic and reconstructive surgery
Lead Sponsor
Department of Biochemistry
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: patients diagnosed with Pan or extended traumatic upper upper trunk brachial plexus injury of less than 7 months requiring surgical repair namely oberlins repair Spinal accessory to Supra spinatous nerve transfer repair via anterior of posterior approach Intercostal nerve to median nerve transfer intercostal nerve to musculocutaneous nerve transfer patients consenting to intra operative bone marrow derived stem cell application at the nerve reapir site and distal nerve No history of malignancies or active infection ability to provide written informed consent and comply with follow up assessments

Exclusion criteria

Exclusion criteria: patients with a history of autoimmune disease or significant immunosuppression presence of systemic conditions affecting nerve reapair outcomes like uncontrolled diabetes and severe vascular disease pregnant of lactating women previous brachial plexus repair surgeries or alternative regenrative therapies for the same injury

Design outcomes

Primary

MeasureTime frame
recruitment rate consent rate retention rate BMSC processing time protocol adherence adverse events bone marrow site painTimepoint: arrival,admission, Post op day 0,3, 1 month, 3 month, 6 month and 9 month

Secondary

MeasureTime frame
muscle strength MRC grading goniometric measurements of shoulder abduction and elbow flexion in degree 10 cm VAS NCS MRITimepoint: at recruitment, 1 month, 3 month, 6 month, 9 month at recruitment,1 month, 3 month, 6 month, 9 month at recruitment, 3 month, 6 month, 9 month 3 month, 6 month, 9 month 6 month, 9 month 6 month, 9 month

Countries

India

Contacts

Public ContactShivam Sharma

All India Institute Of Medical Sciences

drsveena@aiimspatna.org9905755111

Outcome results

None listed

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