A Study to assess the safety and efficacy of instillation of bone marrow derived cells into perineal wounds of patients undergoing surgery for rectal cancer after Chemoradiotherapy with regard to improvement in wound healing.

Is the use of bone marrow derived mononuclear cells safe and feasible in prevention of wound breakdown in patients undergoing abdominoperineal excision after neoadjuvant Chemoradiotherapy for Carcinoma Rectum ? a Pilot study

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000094

Enrollment

Registered

2010-04-19

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

None listed

Interventions

Intervention1: Autologous Bone Marrow derived cells: Single dose local instillation of stromal cells derived from 15 ml of bone marrow aspirate given Intra-op into the perineal wound Control Intervent

Eligibility

Inclusion criteria

Inclusion criteria: Patients diagnosed with carcinoma rectum undergoing Abdominoperineal excision following Long Course Chemoradiotherapy in Surgery Unit 5, using Conventional RT at 50.4 Gy over 28 fractions.

Exclusion criteria

Exclusion criteria: 1.Gross contamination intra op from Rectum or Urethra 2.Known immunosuppression 3. Patients who were diagnosed with hematological disease. 4. Patients receiving conformal radiotherapy

Design outcomes

Primary

Measure	Time frame
Assessment of safety and feasibility of interventionsTimepoint: As assessed intra-op, immediately post-op, in the ward (recovery) and at the first outpatient visit.	—

Secondary

Measure	Time frame
1.Perineal wound breakdown - incidence in this group as compared to historical controls. 2.Factors affecting wound healing Timepoint: As assessed in the ward(recovery) and at the first out patient visit.	—

Countries

India

Contacts

Public ContactDr. Sukriya Nayak

Professor and Head of Dept. General Surgery ,Unit -5

johannboaz@gmail.com09940434252

Outcome results