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Clinical Trials/CTRI/2015/01/005355
CTRI/2015/01/005355
Recruiting
Phase 1

Autologous bone marrow derived progenitor cell therapy in critical limb ischemia (CLI) and foot ulcer in diabetes

KIMS Foundation and Research Center and Krishna Institute of Medical Sciences0 sites48 target enrollmentTBD
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ConditionsHealth Condition 1: null- Critical Limb Ischemia

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Health Condition 1: null- Critical Limb Ischemia
Sponsor
KIMS Foundation and Research Center and Krishna Institute of Medical Sciences
Enrollment
48
Status
Recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
KIMS Foundation and Research Center and Krishna Institute of Medical Sciences

Eligibility Criteria

Inclusion Criteria

  • •1\. Patients aged between 35 â?? 75 years with chronic critical limb ischemia with Rutherford Category IV \& V and Fontaine Scale IV.
  • •2\. Patients failed basic conservative and standard revascularization treatment (Surgical/Endovascular)
  • •3\. Patients with diagnosis of thromboangitis obliterans.
  • •4\. Major amputation recommended due to life threatening PAD.
  • •5\. ABI \<\= 0\.5 or TcPO2 \<\= 40mm Hg or ankle systolic pressure \<\= 60mm Hg
  • •6\. Patients with neuropathy symptoms with DNS score of \>\= 1\.5 and/or DNE score \>\= 5\.0\.
  • •7\. Patients with VascuQOL questionnaire score of \<\=.

Exclusion Criteria

  • •1\. Advanced CLI (Rutherford Category VI), characterized by extensive tissue loss or gangrene.
  • •2\. CLI patient requiring amputation proximal to trans\-metatarsal level.
  • •3\. Subjects with severe COPD
  • •4\. Heart angioplasty or CABG within 3 months prior to enrollment.
  • •5\. Ischemic wounds with uncontrolled infectious symptoms
  • •6\. Subjects with immunodeficient states or receiving immunosuppressive drugs.
  • •7\. Hb \< 8\.5 gm%; serum creatinine \>\= 2\.0 mg%; serum total bilirubin \>\= 2\.0 mg%; HbAlc \> 8\.0%
  • •8\. Renal insufficiency or failure
  • •9\. Hepatic dysfunction
  • •10\. Hematologic or malignant disease

Outcomes

Primary Outcomes

Not specified

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