Phase 2 N=17 Treatment

Safety and Efficacy of Autologous Bone Marrow Mononuclear Cells in Patients With Severe Critical Limb Ischemia

Critical Limb Ischemia

Bottom Line

View on ClinicalTrials.gov: NCT01472289 ↗

Enrolled (actual)

Serious AEs

41.2%

Results posted

Nov 2015

Primary outcome: Primary: Number of Participants With Adverse Events as a Measure of Safety and Major Limb Amputation Free Survival Post BMMNC Administration — 14; 3; 2; 2 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Autologous Bone Marrow Mononuclear cells (BMMNCs) (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: TotipotentSC Scientific Product Pvt. Ltd.
Primary completion: Jan 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Adverse Events as a Measure of Safety and Major Limb Amputation Free Survival Post BMMNC Administration	14; 3; 2; 2; 7	—
SECONDARY Degree of Angiogenesis Measured by the Number of Collateral Blood Vessels Formed at 12 Months	2.42; 5.59	—
SECONDARY Measurement of Mean Change in Ankle Brachial Index From Baseline to 12 Months	0.507; 0.612; 0.819; 0.879; 0.696	—
SECONDARY Measurement of Change in Transcutaneous Oxygen Pressure (TcPO2) From Baseline to 12 Months	14.66; 25.10; 36.85; 34.58; 35.75	—
SECONDARY Change in Rest Pain and Intermittent Claudication Assessment From Baseline to 12 Months	2.80; 1.2; 0.6; 0.4; 0.0; 7.80	—
SECONDARY Clinical Evaluation for the Presence of Ulcer and/or Gangrene in the Affected Limb From Baseline to 12 Months	11; 10; 6; 2; 0	—
SECONDARY Number of Participants Able to Walk From Baseline to 12 Months as Measured by 6-Minute Walk Test	2; 8; 9; 9; 9	—

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.

Eligibility Criteria

Inclusion Criteria

Atherosclerotic ischemic peripheral vascular disease (PVD) or Thromboangiitis Obliterans with severe Critical Limb Ischemia (Rutherford Category 4 and 5: ischemic pain at rest and minor tissue loss and Fontaine Class 4: Ischemic ulcers or gangrene, whivh may be dry or humid).
A non-surgical candidate for revascularization e.g. prior vascular reconstruction, inability to locate a suitable vein for grafting, diffuse multi- segment disease, or extensive infra-popliteal disease not amenable to a vascular graft.
Major amputation recommended patients due to severe life threatening PAD.
Subjects must be on maximal tolerated medical therapy for peripheral vascular disease including A) Cessation of smoking B) Referral to endocrinologist for control of HgA1c to 8.0%.
Women of child bearing potential; pregnant and lactating women.
Subjects with a) myocardial infarction within the last 30 days or left ventricular ejection fraction 1.5 at the time of Bone Marrow harvest.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01472289). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.