CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 17 enrolled
Drug / intervention
Autologous Bone Marrow Mononuclear cells (BMMNCs)other
Likely dose
Multiple intramuscular injections of 0.5 cc/injection of concentrated bone marrow derived mononuclear cellsAI-extracted
Key inclusion· 5
  • ✓Atherosclerotic peripheral vascular disease or Thromboangiitis Obliterans with severe critical limb ischemia (Rutherford Category 4-5 or Fontaine Class 4)
  • ✓Non-surgical candidate for revascularization (prior failed reconstruction, unsuitable vessels, diffuse/extensive disease)
  • ✓Major amputation recommended due to severe life-threatening peripheral arterial disease
  • ✓Ankle Brachial Pressure Index (ABI) ≤0.6 or ankle systolic pressure ≤60 mm Hg or TcPO2 ≤35 mmHg in foot
Key exclusion· 14
  • ✕Suitable candidate for surgical or percutaneous revascularization
  • ✕Amputation level proximal to trans-metatarsal level required
  • ✕Spreading (wet) gangrene
  • ✕Poorly controlled diabetes mellitus

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01472289
NCT01472289Phase 2Completed
CompareCT.gov

To Study and Demonstrate the Safety and Efficacy of RES-Q Prepared Bone Marrow Mononuclear Cells Injected Into Ischemic Tissue of Patients With Non-Reconstructable Critical Limb Ischemia (CLI).

TotipotentSC Scientific Product Pvt. Ltd.·interventional·Posted Nov 16, 2011·Updated Nov 18, 2015

In Brief

A Phase 2 clinical trial evaluating Autologous Bone Marrow Mononuclear cells (BMMNCs) for Critical Limb Ischemia. Completed, enrolled 17 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate the safety and efficacy of the concentrated autologous bone marrow derived stem cells for the treatment of Critical Limb Ischemia patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCritical Limb Ischemia
CountriesIndia
CollaboratorsThermogenesis Corp.

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 16, 2011
Enrollment StartFeb 1, 2011
Primary CompletionJan 1, 2013
Study CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 14.6 years ago

Interventions

Autologous Bone Marrow Mononuclear cells (BMMNCs)other

Multiple intramuscular injections of concentrated bone marrow derived mononuclear cells (0.5 cc/injection) into the ischemic muscle of the affected limb.