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This clinical trial aims to study the safety and efficacy of adult mesenchymal stem cells in critical limb ischemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mesenchymal stem cells | Experimental | Intramuscular injection |
|
| Placebo | Experimental | Intramuscular injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mesenchymal stem cells | Drug | Intramuscular injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AE and symptomatic relief | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Increase in transcutaneous partial oxygen pressure (TcPO2) and Ankle brachial pressure index (ABPI) - measured by Doppler | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suresh K R | Bhagawan Mahaveer Jain Heart Centre, Bangalore | Principal Investigator |
| Sanjay Desai | M.S.Ramaiah Memorial Hospital, Bangalore | Principal Investigator |
| Rajiv Parakh | Sri Ganga Ram Hospital, New Delhi | Principal Investigator |
| Sudhindran S | Amrita Institute of Medical Sciences, Kochi | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M.S.Ramaiah Memorial Hospital | Bangalore | Karnataka | 560054 | India | ||
| Bhagawan Mahaveer Jain Heart Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23758736 | Derived | Gupta PK, Chullikana A, Parakh R, Desai S, Das A, Gottipamula S, Krishnamurthy S, Anthony N, Pherwani A, Majumdar AS. A double blind randomized placebo controlled phase I/II study assessing the safety and efficacy of allogeneic bone marrow derived mesenchymal stem cell in critical limb ischemia. J Transl Med. 2013 Jun 10;11:143. doi: 10.1186/1479-5876-11-143. |
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| ID | Term |
|---|---|
| D000089802 | Chronic Limb-Threatening Ischemia |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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| ID | Term |
|---|---|
| C048013 | Plasmalyte A |
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| Plasmalyte A |
| Drug |
Intramuscular injection |
|
| Bangalore |
| Karnataka |
| 5660052 |
| India |
| Amrita Institute of Medical Sciences | Kochi | Kerala | 682026 | India |
| Sri Ganga Ram Hospital | New Delhi | New Delhi | 110060 | India |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007511 | Ischemia |